eligible ages (years): 18.0-999.0,  All  Diabetes Mellitus Chronic Ulcers of the Lower Limb Age > 18 years Type 1 or 2 Diabetes Mellitus Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks  Impending urgent amputation due to ongoing or exacerbated infection Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed Dialysis-dependent renal failure Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity History of chemotherapy with use of Bleomycin Participation in another investigative drug or device trial currently or within the last 30 days Current candidates for vascular surgery, angioplasty or stenting Major large vessel disease Undergone vascular surgery or angioplasty within the last 3 months Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control


64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.

eligible ages (years): 18.0-999.0,  All  Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Type 1 diabetes Type 2 diabetes Candidates of use of a basal insulin as part of their diabetes regimen  Unwilling to adhere to therapy or follow up Pregnancy


eligible ages (years): 18.0-999.0,  All  Diabetes At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that both medical and pharmacy coverage  Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period Participation in a disease management program


eligible ages (years): 18.0-999.0,  All  Corneal Ulcer The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features corneal epithelial defect with stromal infiltration reaction in anterior chamber positive for bacteria or fungus The patients have to receive subconjunctival antibiotic injection twice at least The patients must be informed consent  The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection Unable to cooperate with the treatment Pregnant women


eligible ages (years): 18.0-999.0,  All  Leg Ulcers • Patients over 18 who have given written informed consent Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to Patients who are available for monitoring for at least 10 weeks  • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment Patients who have undergone surgery on the saphenous trunk within the two months prior to Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to Patients who have been taking systemic antibiotics in the two weeks prior to Patients who have been taking systemic corticoids or cytostatics within the three months prior to Patients with unbalanced diabetes at the discretion of the investigator Patients with a known allergy to one of the components in Biatain Argent® or Biatain Patients who are already taking part in another clinical study Patients who are pregnant or breastfeeding


eligible ages (years): 18.0-80.0,  All  Brain Injury Sequelae Stroke Anoxia Trauma Subject has had a brain injury at least 12 months prior to study enrollment Subject is at least 18 years old Etiology of brain injury: Stroke, anoxia, and trauma Must be able to equalize ears, or have tympanostomy tubes Willingness to complete outcome measures and complies with the research protocols Commitment to pay the hospital for hyperbaric oxygen  Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation Poorly controlled seizures(ie:>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an to participate Inability to participate in outcome assessments (eg: blindness, quadraplegia) Claustrophobia (unwillingness or inability to enter the hyperbaric chamber) Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes Inability to protect airway, and or requiring frequent suctioning Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment) Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not patients based on brain-injury induced psychiatric disorders, but will patients with severe pre-injury psychiatric disorders Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability)


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer In-patient or out-patient patients diagnosed with diabetic foot ulcers Gangrene or ulceration occurred more than 3 weeks Over 18 years of age Gender-open The type of diabetes (type 1 or type 2) open Patients receive a written informed consent to participate in the trial  Serious complications of heart, liver, lung, kidney damage Malignant tumors Allergy for Chinese medicine used Pregnant women and breast-feeding women


eligible ages (years): 18.0-70.0,  All  Trigeminal Neuralgia Pain Age 18-70 Primary TN patient (MRI examination support diagnosis) Suffering from this pain for at least 3 months VAS﹥40mm Patient can assess pain intensity correctly  Undergone surgery for TN(including nerve injections) within the last year Oral medicine change within the last week With other diseases of nervous system


eligible ages (years): 20.0-75.0,  All  CERVICAL NEOPLASMS Histologically confirmed cervical cancer Clinical stage from 2b to 4a Equal to or younger than 75 Gog performance status 0 Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl Serum creatinine < 2.0 AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl Expected survival equal to or longer than 6 months Who agreed to participate in this study  History of chemotherapy or radiation to abdomen or pelvis History of other cancers Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2 History of allergy or hypersensitivity reaction to platinum History of atrial or ventricular arrhythmia, or congestive heart failure Uncontrolled diabetes, hypertension, or ischemic heart disease Myocardial infarction within 6 months Sepsis or severe infection Pregnant women An unapproved therapy within 30 days before enrollment


eligible ages (years): 18.0-999.0,  All  At-risk Drinking Type 2 Diabetes years or older have Type 2 diabetes report at-risk drinking in past month report poor diabetes treatment adherence  current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine) currently psychotic unable to provide the name and contact information for a significant other to corroborate self-report unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone


eligible ages (years): 40.0-70.0,  All  Autologous Transplantation Diabetic Foot Age from 40 to 70 years Type 2 diabetic patients bilateral critical limb ischemia(ABI from 0.30 to 0.60) at least with one foot ulcer  dry gangrene above the ankle or moist gangrene malignant tumor severe coronary,cerebral and renal vascular disease


eligible ages (years): 18.0-999.0,  All  MARTORELL'S ULCER Hypertensive Leg Ulcer Necrotic Angiodermatitis patients 18 years of age or older, able to give informed consent and to follow the treatment procedure target ulcer area between 1 and 30 cm2 consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive ulcers presence of an arterial hypertension, according to the WHO treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index ≥0.8 absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain superficial spreading necrotic ulcer presence of spontaneous pain presence of a red purpuric margin  pregnancy allergy to hydrogel or to becaplermin gel uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder presence of a cryoglobulinemia serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment) concomitant treatment by bone, joint or tendon (except for achilles tendon) exposition in the wound systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before


eligible ages (years): 18.0-999.0,  All  Wounds Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration Subject must be at least 18 years of age Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator The study ulcer must be from 1 cm2 to 20 cm2 in size The study ulcer must have been present for at least 30 days at study Day -7 The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0 The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16. Subjects must be available for evaluation at Week 16 The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7  Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study


eligible ages (years): 0.0-999.0,  All  Diabetes Neuropathic Foot diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant) diagnosed with diabetic peripheral neuropathy palpable or biphasic pulses intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer able to walk a minimum of 10 metres unaided willing to comply with the requirements of the study  presented with current or recently healed ulceration less than 6 months prior to study enrolment severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non bespoke footwear history of major bone or joint surgery of the lower limb including major amputation unable to comprehend simple instructions and comply with the study protocols and procedures


eligible ages (years): 18.0-80.0,  All  Diabetic Foot The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts  Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage The probe-to-bone maneuver was required to be negative Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis Use of steroids or cytostatic drugs Presence of sensory, motor, or visual problems that could impair functional autonomy Active ulcer on the contralateral foot Previous major amputation of the contralateral limb Previous or current deep venous leg thrombosis, OR Mental disorders interfering with patient compliance


eligible ages (years): 18.0-999.0,  All  Foot Ulcer, Diabetic Is the subject 18 years of age or older? Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks? Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided? Does the subject show evidence of neuropathy? Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis? Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes? Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)? Is the subject willing to have photos taken of their wound and permit use of the photos in publications? Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information? Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8  Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year? Does the subject have an infection requiring systemic antibiotic treatment? Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)? Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.) Does the subject have Lupus or Crohn's disease? Does the subject have an oxygen dependency? Has the subject received hyperbaric oxygen therapy within the previous 90 days? Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit? Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?


eligible ages (years): 0.0-999.0,  All  Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy FOR TRIAL PART 1, THE Gender: male Age: 18-55 years BMI (body mass index): 18-28 kg/m2 Study participants considered to be healthy FOR TRIAL PART 2, THE Gender: male or female of no childbearing potential Age: 18-65 years Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 Type 2 diabetes: BMI (body mass index): 22-35 kg/m2  Known or suspected allergy to the trial product or related products Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)


eligible ages (years): 21.0-999.0,  All  Hypercholesterolemia Adults with diabetes LDL greater than or equal to 100 Cholesterol-lowering drug therapy for > 6 months A working telephone At least 2 primary care visits in the past 1.5 years  Poor short-term survival (< 1 year) Inability to understand English Recent major surgery (< 3 months) Patients temporarily in the area Inability to provide consent


eligible ages (years): 30.0-70.0,  All  Type 1 Diabetes Type 2 Diabetes Adult with type 1 or 2 diabetes with or without neuropathy  Pathology affecting bone metabolism abnormalities of phosphate metabolism proved biologically hepatic chronic alcoholism renal insufficiency (creatinine clearance < 60 ml / min) hyperthyroidism intoxication active smoking occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9) Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months) Known HIV positive serology Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory)


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer Patient is 18 years of age or older Patient has type I or II diabetes Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care Foot ulcer is on the plantar surface of the forefoot or heel Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization) Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue Patient's Ankle-Arm Index by Doppler is >/=0.7 Patient has adequate circulation to the foot as evidenced by a palpable pulse Female patients of child bearing potential must not be pregnant and must use accepted means of birth control  There is clinical evidence of gangrene on any part of the affected foot The study ulcer is over a Charcot deformity The study ulcer is due to a nondiabetic etiology The ulcer has tunnels or sinus tracts that cannot be completely debrided The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm) The ulcer has increased or decreased in size by 50% or more during the screening period Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study Presence of a malignant disease not in remission for 5 years or more Evidence of severe malnutrition, based on a serum albumin level <2.0 Presence of patient having known alcohol or drug abuse


eligible ages (years): 18.0-90.0,  All  Pressure Ulcers patient between 18 and 90 years old patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers pressure ulcers were less than 2cm-deep limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8 signed informed consent  patients pregnant or lactating patients with neuropathy patients perforant ulcer of the foot patients with dementia


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer of Neuropathic Origin Selection Patients who fulfill all of the following (and none of the  described below) are eligible to enter the placebo run-in phase of the study Provide written informed consent to participate Male or female patients age 18 years or older Type 1 or 2 diabetes A single full-thickness DFU that has been present for at least 2 weeks DFU wound surface area below or equal 34 cm2 on the target foot No exposure of bone in the target DFU Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament) No predominant ischemia requiring further exploration or treatment, and confirmed by either ABPI on the target leg ( >0.9;below or equal 1.3) or if ABPI is >1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR


eligible ages (years): 18.0-999.0,  All  Cesarean Section Cicatrix Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started Woman who speak and understand Danish Woman who can give informed consent  Level I or II caesarean section (ordered less than 30 min. before surgery is started) Diabetics (this does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 Chronic pain disease eg fibromyalgia, rheumatoid arthritis BMI over 35 Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time)


eligible ages (years): 18.0-90.0,  All  Chronic Skin Ulcers Chronic wound needing debridement >3 cm2 Ulcer history >4mo Adequate arterial blood flow (ABI>0.7) Venous, Inflammatory, Pressure, Diabetic  Bleeding disorder ABI<0.7 Uncontrolled diabetes Taking systemic corticosteroids Chemotherapy Participating in another study Treatment with Apligraft, Dermagraft, or Regranex within 90 days


eligible ages (years): 49.0-69.0,  All  Diabetes Mellitus Clinical diagnosis of Diabetes mellitus Must be obese  Previous radiotherapy to the foot previous trauma to the foot (fracture, rupture of tendon) rheumatic or vascular diseases malign diseases lymphatic edema


eligible ages (years): 18.0-50.0,  All  Vitamin Deficiency Male and female between 18 years old Immigrants with background from Middle East, Africa and South Asia  Daily use of vitamin D supplementation and frequently use of artificial UV light exposure Pregnancy Malabsorptive disorders Fracture in the leg /arm within the preceding 6 months. Known osteoporosis Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates Regular use of strong pain killers Medication for diabetes


eligible ages (years): 18.0-90.0,  All  Lower Limb Ulcer patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²) patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis not eligible for skin flap surgery the patient or patient's representative has agreed to sign the information letter before any investigation required by the research  circumferential wound wound infection immunosuppressed patient known allergy to bovine collagen, bovine glycosaminoglycans or silicone patients under legal guardianship pregnant women patients whose health would compromise follow-up for at least 18 months patients whose mental health would compromise completion of the self-evaluation questionnaires wound located in an area not visible by the patient (as no self-assessment would be possible)


eligible ages (years): 18.0-999.0,  All  Moderatley to Highly Exuding Venous Leg Ulcers Subject > 18 years Subject is attending weekly office visits at SW Wound Care Center as an out-patient Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment Subject is willing and able to comply with all specified care and visit requirements  Subject has a lesion that does not meet the criteria Subject refuses to participate in the study Subject already participates in the this study with one wound (only one wound per subject is allowed) Subject has known sensitivity to the trial product or any of its compounds Subject is expected to be non-compliant Subject's lesion is a primary skin cancer Subject's lesion is the manifestation of a metastasis Subject is pregnant


eligible ages (years): 18.0-999.0,  All  Metabolic Syndrome Impaired Glucose Tolerance Gestational Diabetes Dark Skin Tone (Von Luschan chromatic skin color > 35) Age greater than or equal to 45 years Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following diabetes risk factors Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week) Has a first-degree relative with type 2 diabetes African American, Latino, Native American, Asian American, Pacific Islander Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes Hypertension (≥140/≥ 90 mmHg) or being treated for hypertension HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)  Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712 Under 18 years of age Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis Diagnosed with any type of diabetes, including type 1 or 2 Taking glucose lowering medications Known to be pregnant Receiving dialysis or having known renal compromise Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm


eligible ages (years): 18.0-999.0,  All  Pressure Ulcers ED and ICU admission for critical illness and/or major trauma Over 18 years old  Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area


eligible ages (years): 40.0-75.0,  All  Diabetes Mellitus Polyneuropathies Arthropathy, Neurogenic Patients with type 2 diabetes with and without polyneuropathy Patients with type 2 diabetes with a history of Charcot's disease Healthy controls Signed informed consent  Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication Renal insufficiency: MDRD creatinin clearance < 30 ml/min Systemic disease such as vasculitis or rheumatoid arthritis Malignancy (Diabetic) foot ulcer Gout Bacterial infection of an extremity Skin condition of the dorsal aspect of the foot or the medial side of the upper arm Bleeding disorder such as hemophilia Use of medication for asthma


eligible ages (years): 18.0-999.0,  All  Venous Ulcer Infection Is 18 years or older; male or female Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux Has a venous ulcer with a wound area between 5 cm2 cm2 Has an ankle brachial index (ABI) >0.8 Has a venous ulcer with duration less than 24 months Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation Is currently using Profore as their standard of care Has not received antibiotics for 6 weeks prior to enrollment  Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver) Is currently on antibiotics Has a negative venous duplex Is unable to tolerate 4 layer compression Is unable to continue contact with the investigator for a period of at least two weeks Is unwilling or unable to comply with the study protocol


eligible ages (years): 18.0-999.0,  All  Neuropathic Diabetic Ulcer - Foot Subject is ≥18 years of age and has type 1 or 2 diabetes Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts Prior to of an ulcer in the study, each wound will be reviewed for by an independent assessor using a central online review process that includes images of the ulcer For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer Ulcer size between 1 cm2 and 12 cm2 (post-debridement) Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all including lack of ulcer healing until day 0 Study ulcer separated from other ulcers by at least 2 cm Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection) Post-debridement, ulcer free of necrotic tissue Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2; (b) toe pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion pressure (SPP) > 30 mm Hg  Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.) Presence of underlying osteomyelitis Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection History of alcohol or substance abuse, within the previous 2 months Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis) Subject has been treated with wound dressings that growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization or is scheduled to receive during the study Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study Wound on a patient who has a life expectancy of less than 12 months Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form


eligible ages (years): 18.0-999.0,  All  Lower Extremity Diabetic Leg Wounds Lower Extremity Venous Leg Wounds Lower Extremity Mixed Aetiology Leg Wounds Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease) Wound present for >30 days Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings Patient is able to comply with study protocol requirements Patient is able to understand and provide written consent  Patient has evidence of wound infection in the opinion of the physician Patient has a thick eschar that persists after wound debridement Patient has an HbA1C >12% Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis Patient has untreated osteomyelitis Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study Patient is allergic to the wound care device or occlusive dressing Patient has exposed blood vessels Patient is pregnant or pregnancy is suspected Patient is actively participating in other clinical trials that may interfere with their participation in this study


eligible ages (years): 3.0-999.0,  All  Mycobacterium Ulcerans Disease Buruli Ulcer Patients with a clinical picture of Buruli ulcer disease in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of antibiotic treatment All stages of the disease will be included. Only patients with confirmed disease by direct microscopy following acid-fast staining or PCR will be included  Patients not on the standard treatment of eight weeks of rifampicin and streptomycin for any reason, will be excluded from this study Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immune-modulatory drugs including corticosteroids within the previous one month Patients not compliant with the antibiotic therapy will be excluded as well. Non-compliance is defined as the use of < 70 % of the prescribed antibiotics Patients with a contraindication for general anaesthesia are not able to participate Pregnancy Osteomyelitis Lesion close to the eye, with preferred standard treatment to wait for effect antibiotic treatment on extent surgery The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children below three years and therefore will not participate Patients reporting to refuse surgery at any point in the intended treatment, cannot be included Any situation or condition which may compromise ability to comply with the trial procedures


eligible ages (years): 18.0-999.0,  All  Varicose Ulcer Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the duration of the study Patient who agrees to wear effective venous compression every day, associated with the trial dressing Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2 Ulcer duration between 3 and 36 months Ulcer where the surface area is 70% or more covered by fibrinous tissue Ulcer at least 3 cm away from any other lesion Ulcer moderately or strongly exudative justifying the use of an absorbent dressing  Female patient of child-bearing potential who has no effective means of contraception Patient who is pregnant or breastfeeding Patient taking part in another therapeutic trial Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid) Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy Patient with a systemic infection not controlled by suitable antibiotic treatment Patient who, during the 3 months before presented a deep vein thrombosis Ulcer where its surface is totally or partially covered by black necrotic plaque Ulcer which is clinically infected


eligible ages (years): 18.0-90.0,  All  Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014  Not willing to participate Drop out at 3 week follow up


eligible ages (years): 20.0-62.0,  All  Ischemic Ulcer Ischemic lower limb based on TASK guide line Rutherford score:2,3 ABI<0.6 Absolute ankle pressure < 60 mmHg Both gender Age:20-62years  EF<30% Cr>2 HbA1c>8% Bone marrow disorders:leukemia Cognitive disorders Infections MI with ST elevation during last month Malignancy Immunologic or rheumatologic disorders


eligible ages (years): 18.0-70.0,  All  Diabetic Foot Ulcer Adult diabetic foot syndrome subjects over 18 years of age of any sex All stages of diabetic foot syndrome including Wagner stage 5 Mid-foot gangrene only after appropriate surgical treatment Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome Stable metabolic and pharmacological control at recruitment and during the trial period Adequate perfusion of lower limb as measured by HHD and confirmed by APSV  Non-diabetic foot ulceration (traumatic, thermal ulceration etc) Diabetic foot syndrome graded 5 on Wagner's scale hind foot gangrene only Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized Presence of slough or sequestrum unless debrided Hemoglobin less than 8 g/dl unless corrected Those receiving NSAIDs, steroids or anti-mitotic drugs Septicemia patients requiring urgent amputation


eligible ages (years): 0.0-999.0,  All  Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy


eligible ages (years): 40.0-75.0,  All  Foot Ulcer, Diabetic between ages 40 and 75 history of diabetic neuropathic plantar ulcer (test subjects) no history of diabetes (control subjects) no peripheral sensory neuropathy (control subjects)  amputation or surgery on right Great Toe


eligible ages (years): 0.0-999.0,  All  Osteoarthritis, Hip Joint Deformities, Acquired Hip Dislocation, Congenital Osteonecrosis Arthritis, Rheumatoid Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year  Patients with pre-existing known coagulopathy Patients on chronic Coumadin (Warfarin) therapy Patients receiving erythropoietin therapy for anemia


eligible ages (years): 18.0-75.0,  All  Ottawa Score Adenoma patients undergoing colonoscopy  disturbance of water and electrolyte history of colorectal surgery severe colonic stricture or obstructing tumor known or suspected bowel obstruction or perforation toxic colitis or megacolon dysphagia compromised swallowing reflex or mental status significant gastroparesis or gastric outlet obstruction or ileus severe chronic renal failure (creatinine clearance ＜30 mL/minute) severe congestive heart failure (New York Heart Association class III or IV)


eligible ages (years): 18.0-999.0,  All  Diabetes Mellitus Diabetic Neuropathic Foot Ulcer More of 18 years old man or woman Type 1 or 2 Diabetes mellitus A new plantar ulcer of the fore foot or the toes GRADE 1A or 2 A of the University of Texas Classification Neuropathy assessed by absence of sensation in 10g monofilament test  Severe angiopathy (Grade 3 of the PEDIS classification) Osteomyelitis or cellulitis of the foot Transmetatarsal amputation Other study in course Immunosuppressive drugs, antibiotic therapy Hepatic insufficiency No possibility to follow the patients every 14 days No state health insurance Pregnancy


eligible ages (years): 18.0-999.0,  All  Ulcer Skin Ulcer Leg Ulcer Diabetic Foot Patient is 18 years old or older Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult Study ulcer/wound has been present for greater than 6 weeks prior to initial consult Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening  An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study Patient has clinical evidence of gangrene or infection on any part of the affected foot The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis) Patient has muscle, tendon, or bone exposure in any ulcer bed Patient has known sensitivity or allergy to any component of the study product Olivamine10 Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the Investigator would make the patient an inappropriate candidate for this wound healing study Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more


eligible ages (years): 18.0-999.0,  All  Peripheral Artery Disease Without Critical Limb Ischemia Patients need to be at least 18 years old Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months Patients will be hospitalized in the Dermatology inpatient clinic Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization Before in the study, patients must undergo complete angiological diagnostic work-up including A baseline ABI, toe pressure and tcPO2 measurements A non-invasive arterial imaging including an angio-CT scan or an angio-MRI The non-invasive arterial work-up must revel mild to moderate PAD, without any or sign of CLI (see flow-chart) Ankle pressure ≥ 50 mmHg  Patients who refused to give their written informed consent Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2) Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 < 1.3, TP > 100mmHg, tcPO2 > 40mmHg) Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.) Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal) In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy


eligible ages (years): 5.0-20.0,  All  Neurogenic Bladder Diagnosis of spina bifida and neurogenic bladder Performing clean intermittent catheterization (CIC) Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder Has not had previous bladder surgery Has had a urodynamic or videourodynamic study done within the last 6 months Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity Able and willing to complete CIC Diaries and Quality of Life Questionnaires Consent and assent given to participate in trial  History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia Positive urine culture Known allergy to Botox


eligible ages (years): 10.0-17.0,  All  Type 1 Diabetes Mellitus English-speaking patients to 18 years diagnosed with type 1 diabetes for at least 12 months poor diabetes control as defined by having a hemoglobin A1c value > 8%  type 2 diabetes developmental delay current participation in another study that may impact glycemic control


eligible ages (years): 18.0-999.0,  All  Detrusor Function, Overactive Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs stroke-sudden loss of blood supply to brain) Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control Overactive bladder symptoms and/or has urge incontinence episodes Must have normal results on urine culture tests and on urinalysis ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3  Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded]) Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose) Pregnant or breast feeding female Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine


eligible ages (years): 45.0-65.0,  All  Fibromyalgia fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure  any past hyperbaric oxygen therapy chest x-ray pathology which does not allow the income into the hyperbaric chamber middle ear problems patients, who cannot "pump", equals middle ear pressure, effectively patients who suffer from claustrophobia inability or Refusing to sign the Informed Consent Form


eligible ages (years): 18.0-69.0,  All  Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results Specific for subject with type 1 diabetes Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Specific for subject with type 2 diabetes Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening Treated with insulin for the past 3 months prior to screening Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)  Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator Subject with a history of or presence of cancer Any condition that the Investigator and/or Sponsor feels would interfere with study Specific for subject with type 2 diabetes Therapy with oral antidiabetic drugs within the past 3 months prior to screening


eligible ages (years): 18.0-92.0,  All  Bowen's Disease Korean patients aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities  porphyria known allergies to the MAL cream or lidocaine pregnancy lactation any active systemic infectious disease immunosuppressive treatment personal history of malignant melanoma tendency towards melasma or keloid formation prior treatment of the lesions within 4 weeks, and any indication of poor compliance


eligible ages (years): 18.0-999.0,  All  Chronic and Acute Wounds, Diabetic Foot Ulcers and Venous Leg Ulcers Below the Knee Subjects who meet the following may be included in the clinical investigation, if they present with ALL of the following Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures Age 18 years and older. Subjects may be of either sex and of any race or skin type Subjects fulfilling any one or all of the following chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma diabetic foot ulcer(s) subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression) Subjects with the following lab results within 30 days of treatment serum albumin level >20g/L  Subjects will be excluded from the clinical investigation, if they present with ANY of the following Subjects that have tunneling wounds Subject presents with an active infection in the study wound, as defined by purulence and Fever and leukocytosis OR any TWO of the following Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images) Subjects whose study wound does not require debridement Cardiac pacemaker or other electronic implant(s) Subjects with irradiate, burn or ischaemic wounds or history of keloids


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer Is aged ≥ 18 Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Meets certain minimal laboratory criteria  Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period


eligible ages (years): 18.0-999.0,  All  Leg Ulcer Diabetic Foot Ulcer Pressure Ulcer Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer Male of female, 18 years and above Signed Informed Consent Form  Pregnancy or lactation Wound size not suitable for the wound dressing size Known allergy/hypersensitivity to any of the components in the dressing


eligible ages (years): 18.0-60.0,  All  Post-concussion Syndrome Adults, age 18-60, both men and women Able to speak and read English as primary language Able and willing to provide written informed consent for study participation Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure Past history of at least one mild traumatic brain injury with persistent symptoms that meets all of the following 1) Brain injury occurred at least 1 year but no more than 5 years prior to enrollment; 2) Brain injury occurred as an adult (at least 18 years of age); and, 3) Brain injury occurred due to non-penetrating trauma and is graded as mild At least 3 of the following persistent post-concussive symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, or ringing in the ears  Diabetes mellitus Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months) Claustrophobia precluding chamber or hood tolerance Implanted devices not cleared for hyperbaric pressurization Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control through the 13-week assessment visit Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease, that raises the risk for pulmonary barotrauma due to air trapping Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygenation Prior military service in theater Alcohol abuse, by self-report, within the last year


eligible ages (years): 18.0-999.0,  All  Varicose Ulcer Male or female over the age of 18 years Chronic venous ulceration Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 Ulceration present for at least four weeks Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction  Acute infection in the studied lower limb within the last four weeks History of malignancy in the lower limb to be studied History of connective tissue disease Patients on medications that can cause immunosuppression Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications


eligible ages (years): 20.0-999.0,  All  Pressure Ulcer Wound Necrosis over 20 years of age subject who has untreated wounds subject who has wound size over 3cm x 3cm subject who has wound over stage 2  cellulitis


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Pedal Ulcers Men or women >18 years old One or more foot ulcers without clinical evidence of osteomyelitis Diagnosis of Diabetes Mellitus* University of Texas Grade 1A, 1C, 2A, or 2C ulcer15 ABI >0.7 and Toe pressure >30mmHg  Limited life-expectancy Wounds on calf or shin that would be in contact with the TAG Brace Gangrene, active infection Osteomyelitis of the foot with the ulcer Chronically bedridden/Non ambulatory Unable to keep research appointments Wide spread malignancy or systemically immunocompromising disease Ipsilateral revascularization procedure within the last 30 days Unreliable, unwilling or unable to comprehend informed consent


eligible ages (years): 14.0-24.0,  All  Diabetes Mellitus Type 1 diabetes Males and females Age between 14-24 years Any diabetes duration Cared for by the diabetes center for at least 1 year HbA1c ≥ 8% Basal bolus treatment (any insulin) Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks) Written informed consent obtained from patient or legal representative (for minor)  Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion Refusal or inability to give informed consent to participate in the study Patients with short life expectancy Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment Requirement for concomitant treatment that could bias primary evaluation Patients with high likelihood of being unavailable for 6 and/or 12 months visits Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study Current addition/abuse of alcohol or drugs Severe visual or dexterity impairment Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study


eligible ages (years): 18.0-75.0,  All  Diabetic Foot Ulcer diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2  previous vascular surgery on the side that the ulcer is present uncontrolled diabetes mellitus presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3


eligible ages (years): 19.0-999.0,  All  Type 2 Diabetes Mellitus age >19 years of age type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes A1C ≥8% in past 1 year willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments ability to provide informed consent self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi  life limiting illness <12 months physical inability to exercise recurrent severe hypoglycemia or hypoglycaemic unawareness family member of, or living in same household as a participant pregnancy or gestational diabetes


eligible ages (years): 18.0-80.0,  All  Atopic Dermatitis Eczema Male or female subjects who are not pregnant or lactating 80 years of age Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic for atopic dermatitis Presence of lesional atopic dermatitis skin in both antecubital fossae Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit  Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion (one week prior to the screening, treatment and follow-up visits for topical medications and 28 days prior to screening, treatment and follow-up visits and for oral medications) Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol Active bacterial, viral or fungal skin infections Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection


eligible ages (years): 18.0-80.0,  All  Diabetes Mellitus Diabetes Complications Diabetic Neuropathies Wound Infection an adult patient (18-80 years) suffering from infected neuropathic fore or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II)  a patient whose life expectancy is less than 6 months an ulceration of ischemic or neuroischemic origin presence of systemic inflammatory response signs heel ulceration presence of osteomyelitis pregnancy known hypersensitivity to any of the ingredient including in the study or control treatment products a patient who is unable to give informed consent a patient who has an advanced malignant disease


eligible ages (years): 5.0-18.0,  All  Ulcerative Colitis (UC) Informed consent Established diagnosis of UC disease Age: 5 years ( inclusive) Mild to moderate active disease, 10 ≤ PUCAI ≤45 Stable medication (IMM/ 5ASA) use for the past 6 weeks For patients who received antibiotic treatment: age 10-18 (inclusive)  Any proven infection such as positive stool culture, parasite or C.difficile Use of Antibiotics Use of steroids in the previous two weeks only Patients that are refractory to full dose steroids ( 1 mg/kg/day) Past acute severe UC Current Extra intestinal manifestation of UC Pregnancy A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcers Men or women Type 1 or 2 diabetes Age ≥ 18 years Wagner 1 or 2 diabetic foot ulcer Diabetic ulcer for more than 8 weeks duration Willing to participate in the study with signed informed consent  Ankle/brachial index < 0.4 (critic ischemia) Use topical or systemic antibiotics Inability to attend to the weekly evaluations Inability to do daily ulcer cleansing Autoimmune diseases Active pharmacologic topical or systemic ulcer treatment Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy Pregnancy or lactation


eligible ages (years): 18.0-999.0,  All  Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment  Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer Wagner groups 1 and 2 (Wagner Ulcer Classification System)  Patients with an ulcer duration of less than 2 months Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2) Patients who have had vascular surgery performed within the past 2 months Patients who cannot give informed consent Patients who do not read or speak danish Wagner groups 3 and 4 (Wagner Ulcer Classification System)


eligible ages (years): 21.0-999.0,  All  Diabetic Foot Ulcers Bacterial Infection Veterans over 21 years of age with chronic diabetic foot ulcers (wound duration over 8 weeks) who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue) wound size 1.5 cm (roughly the size of a quarter) or larger in diameter  Cognitive impairment that would interfere with patient signing own Informed Consent Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) *Nasal steroid sprays will not be excluded Active systemic antibiotics is an Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an (indicates critical limb ischemia) Other possible reasons participants could be removed from this study transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer Type 2 Diabetes Male or female, age ≥ 18 Type 2 Diabetes A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system Hemoglobin A1c ≥ 5.9% Ability to provide written informed consent  Any experimental drugs taken orally or topically within 4 weeks of study entry Malignant disease at/or in proximity to the DFU Target wound of malignant origin Failure to satisfy at least one criterion for one of the two study groups


eligible ages (years): 18.0-70.0,  All  Eczema Healthy male or female ≥ 18 and ≤ 70 years of age Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2 Subjects with mild to moderate eczema; determined at screening visit Judged by the Investigator to be in general good health on the basis of medical history Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin Agree to stop all medications and supplements during the entire length of the study Females of child bearing potential must agree to use appropriate birth control methods during the entire study period Agree not to initiate any new exercise or diet programs during the entire study period Agree not to change their current diet or exercise program during the entire study period Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator  Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder Known allergy or sensitivity to Herbal products History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse Participation in a clinical study with exposure to any non-registered drug product within 30 days prior Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study Smoking must be nonsmoker for at least 12 weeks prior to screening


eligible ages (years): 18.0-999.0,  All  Central Retinal Vein Occlusion Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months Patients who signed an informed consent form  Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent


eligible ages (years): 18.0-85.0,  All  Foot Ulcer, Diabetic Infection Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (CID 2012; 54:132-173) (IDSA guidelines) has ≥ 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion) has ≥ 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut) Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure ≥ 45 mm Hg or participation is approved by a vascular surgeon) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Has received appropriate surgical debridement to remove all gangrenous tissue  Has a known history of hypersensitivity to gentamicin (or other aminoglycosides) Has a known or suspected hypersensitivity to bovine collagen Has an ulcer infection which, based upon the patient's known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol Has an ulcer associated with prosthetic material or an implanted device Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator Has a history of epilepsy Has a history of alcohol or substance abuse in the past 12 months


eligible ages (years): 18.0-999.0,  All  Diabetes Mellitus, Type 2 Adults 18 years and older (to be confirmed by electronic health record) Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM) Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic Registered My Health at Vanderbilt user Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record)  Non-English speakers (determined by a trained research assistant) Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant) Individuals with delirium or a severe cognitive impairment (determined by a lack of orientation to person, place, and time) Individuals who report a caregiver administers their diabetes medications Individuals who report they do not have a mobile phone or computer with internet access Individuals unwilling and/or unable to provide written informed consent


eligible ages (years): 18.0-999.0,  All  Ulcer Wounds A signed and dated informed consent has been obtained from the subject Subject is able and willing to comply with study procedures Subject is able to comply with weekly visits Subject is 18 years of age or older There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2 Subject will not have currently used parenteral or oral antibiotics except for UTI Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory  Steroid use >5mg daily Subject is unable to cooperate with offloading and/or compression recommendations ABI = or >0.8 if the wound is located on a lower extremity Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment Subject has medical instability as deemed by the investigator Subject is pregnant Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment


eligible ages (years): 18.0-80.0,  All  Foot Ulcer Varicose Ulcer Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo Patients of both sexes Patients over 18 years Patients that have basic laboratory at admission (complete blood count with differential) Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc  Hemodynamically unstable patients Patients with septic shock from any source Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure Patients with secondary cutaneous ulcer enteral fistula Patients with cutaneous ulcer or cancer tumors Patients with cutaneous ulcer with active bleeding Patients with cutaneous ulcer necrosis Patients with cutaneous ulcer leishmania, insect bite Patients with cutaneous ulcer burns Patients who do not accept their participation in the study through informed consent


eligible ages (years): 0.5-85.0,  All  Xerosis Cutis Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study Child specific written informed consent, if over 7 years of age Subjects with a general good and stable health condition Subjects with clinically stable medical conditions Accept to abstain from sunbathing and solarium during the study Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs TEWL > 12 g/m2/h on the left mid volar forearm  Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars Suffering from porphyria Suffering from severe photodermatoses according to the judgment of the investigator Clinically significant, possibly unstable medical conditions such as metastatic tumor Currently having other malignant or benign tumors of the skin in the investigational area Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol Use of (medical) oil-containing bath additives or other oil-containing cleansers Current topical or systemic treatment affecting the skin, e.g. diuretics Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before


eligible ages (years): 18.0-65.0,  All  Infection Cohort 1: Diabetic hyperbaric patients with active, chronic infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications diabetic lower extremity wounds or refractory osteomyelitis) Diabetes mellitus Current antibiotic use for active infection  Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy Cohort 2: Hyperbaric patients without diabetes or active infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications crush injury, acute peripheral arterial insufficiency, or radiation necrosis) Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy


eligible ages (years): 18.0-999.0,  All  Leg Ulcers Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the whole duration of the study Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer area > or equal to 5cm2 Ulcer duration > or equal to 6 months Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue Moderately or heavily exudative ulcers  Clinical infection on the wound bed


eligible ages (years): 18.0-100.0,  All  Diabetes Diabetes Complications Neuropathy Peripheral Neuropathy Diabetic Foot Ulcer Diabetes (according to AAFP diagnostic ) Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS) Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , ) A minimum size ulcer ≥1cm2 and ≤ 12 cm2 post debridement at time of randomization If the subject has more than one ulcer, they should be identified and at least 2 cm apart The duration of the study ulcer is at least 30 days at the time of the screening visit Age >18 At least one palpable foot pulse Ability to understand all of the study requirements Life expectancy greater than the duration of the study  Weight > 400 lb (182 kg) Uncorrected visual impairment Active Infection Non-plantar ulcers on the ankle, posterior heel, or other location More than one active plantar ulcer Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3) Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study Current smokers Active abuse of alcohol o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process


eligible ages (years): 18.0-999.0,  All  Lower Limb Ulcers Patient is 18 years of age or older Patient has one of the following difficult-to-treat chronic ulcers in the lower limb 1. Neuropathic lower limb ulcer 2. Venous lower limb ulcer 3. Post traumatic lower limb ulcer 4. Post operative lower limb ulcer In case of Neuropathic foot grade according to University of Texas Classification 1A Wound area measurement ranging between 1-20cm2  Acute ulcer Multiple Ulcers on the lower limb Clinical evidence of infection in the soft tissue, joint and/or bone (osteomyelitis) as presented in the physical examination The wound is penetrating into deep structures and involves bone tendon or joint Wound has necrotic tissue Wound with sinus tracts HbA1c>12 Patients with any other skin disorder unrelated to the ulcer that is


eligible ages (years): 18.0-60.0,  All  Diabetic Foot Ulcer Subject is between 18 years and 80 years of age Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit Ulcer located the foot, and ulcer size is between 1 cm2 and 25 cm2 Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2) Ulcer is free of necrotic debris Subjects had adequate circulation to ulcer as documented by either Palpation of pulses around ulcer using Doppler exam Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg Subject is able to give written informed consent prior to study start and to comply with the study requirements  Ulcer is of non-diabetic pathophysiology The ulcer has increased or decreased in size by 30% or more during one week after the screening visit Subject is Human Immunodeficiency Virus (HIV) positive Subjects with severe hepatic deficiencies Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15% Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue Subjects requiring intravenous (IV) antibiotics to treat the index wound infection Subjects who are currently receiving dialysis Subjects who are pregnant or breast-feeding Subjects who are unwilling to use an "effective" method of contraception during the study


eligible ages (years): 18.0-999.0,  All  Diabetes Mellitus Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies) Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months


A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.

eligible ages (years): 18.0-999.0,  All  Bipolar Disorder Patients must have Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry Required Current treatment with lithium carbonate


eligible ages (years): 8.0-18.0,  All  Bipolar Disorder Depression Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant  Patients with schizophrenia, autism, schizoaffective disorder, organic mood disorder, obsessive-compulsive disorder, eating disorder, and psychosis. IQ less than 70. Significant chronic medical illness such as diabetes, epilepsy. Pregnancy. Substance abuse in last 3 months. Concurrent psychotherapy. Previous lack of response to adequate treatment with fluoxetine or other SSRI. Current use of psychoactive medication other than lithium or valproate


eligible ages (years): 18.0-65.0,  All  Tobacco Use Disorder Smoke at least 10 cigarettes per day Report concern about cessation-related weight gain Motivated to quit smoking  Currently pregnant, lactating, or no medically approved method of contraception Major medical problem History of seizure disorder or head injury Current or historical psychosis or bipolar disorder History of alcohol or substance abuse within previous year Current or historical eating disorder Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month Multiple Drug Allergies Current major depressive disorder


eligible ages (years): 15.0-999.0,  All  Bipolar Disorder General current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways) able to give informed consent for data to be harvested meet DSM-IV for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies meet with Clinical Specialist as scheduled able to complete all Study Registry Forms within 3 months of registration General  unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations) not competent to give informed consent in the opinion of the investigator (e.g., psychotic) Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month


eligible ages (years): 18.0-75.0,  All  Bipolar Disorder ARE NOT BEING FOR THIS STUDY FOR Patients must meet the following in order to participate in the study Male or female inpatients in need of treatment for severe bipolar depression 18-75 years of age Women of childbearing potential must be using an adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method (women who are on an OCP will be kept on it others must agree to use only a barrier method) DSM-IV diagnosis of bipolar depression I/II, severe, with or without psychotic features A current major depressive episode of at least 6 weeks' duration Score of greater than or equal to 18 on the first 17-item HAM-D at the prestudy visit and at the first baseline phase visit Score of 15 or greater on the HAM-D (17) at the end of the baseline period(s) (i.e., at randomization no more than 20% less than entry enrollment criteria)  FOR Patients will be excluded from the study if they meet any of the following Women who are pregnant, intending to become pregnant in the next month or breast-feeding Treatment with any of the following therapies within the specified interval prior to baseline: Fluoxetine weeks; Investigational compounds 4 weeks; MAOIs 1 week; Other antidepressants 1 week Contraindication or history of hypersensitivity to mifepristone as well as cortisol, and CRH Clinically significant organ system disease where mifepristone would be contraindicated or interfere with medical treatment Have evidence of any disorder that represents a contraindication to the use of mifepristone (such as adrenal disease or a condition requiring chronic corticosteroid administration) History of Addison's Disease, Cushing's Disease, insulin dependent diabetes, or other uncompensated endocrine conditions Evidence of infection, severe liver, respiratory, or renal disease


eligible ages (years): 18.0-65.0,  All  Schizophrenia Psychotic Disorders Bipolar Disorder You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine You must be able to visit the doctor's office as scheduled for the next 4 months  You have a history of an illness that would cause weight loss or gain in the near future You have taken remoxipride within the past 6 months You are allergic to olanzapine or Anti-obesity Agent You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke You have a serious medical illness, such as heart, liver, or kidney disease You are pregnant or breast feeding


eligible ages (years): 16.0-999.0,  All  Bipolar Disorder Bipolar I or II Disorder Meet for rapid cycling, defined as four or more episodes over the past 12 months Meet for a major depressive episode  History of intolerability of lithium, divalproex, or lamotrigine


eligible ages (years): 15.0-999.0,  All  Depression Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale Child who is 6 weeks to 30 months old Child who is enrolled in an Early Head Start program  Regular use of psychotropic medication Regular use of psychotherapy or drug/alcohol treatment


eligible ages (years): 0.0-999.0,  All  Alzheimer Disease Patient is between the ages of 40 and 90 (inclusive) Patient will have a diagnosis of AD; the study will be confined to patients who are able to provide consent (pass a capacity assessment) The modified Hachinski Ischemia Score must be less than 4 Brain MRI performed within 15 months of enrollment must be compatible with the diagnosis of AD Patient and/or caregiver are willing to adhere to protocol requirements as evidenced by written, informed consent  Patients meeting any of the following during screening or during the study will not be enrolled or will be immediately excluded from the study, as appropriate Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk Patient has clinically significant laboratory abnormalities that would preclude administration of lithium and divalproex Patient is taking a prohibited concomitant medication. The following medications are forbidden for at least one month prior to the treatment phase (unless otherwise noted) and during the course of the study Any investigational drugs Anti-depressants (eligibility will be considered as long as dosage remains stable throughout the study) Anticonvulsants and other mood stabilizing drugs Treatment that may provoke lithium toxicity due to reduced renal clearance, including metronidazole, spectinomycin, tetracycline Treatment that may substantially increase steady-state plasma lithium levels resulting in lithium toxicity, including angiotensin-converting enzyme inhibitors, diuretics


eligible ages (years): 18.0-55.0,  All  Cannabis Dependence Substance Withdrawal Syndrome DSM-IV diagnosis of cannabis dependence with at least a three-month history Seeking treatment for primary cannabis problem Withdrawal identified as barrier to abstinence  Other drug dependency (excluding nicotine) Client is breastfeeding or pregnant Client has contraindicated medical or psychiatric conditions Client currently taking other medications that may interact with lithium Known hypersensitivity / side effects with Lithium Currently receiving Lithium from another source Currently prescribed any antidepressant / mood stabilising / antipsychotic medication Currently receiving opioid pharmacotherapy


eligible ages (years): 8.0-17.0,  All  Bipolar Disorder Attention Deficit Hyperactivity Disorder Age: 8-17 BD type I or II comorbid with ADHD Baseline score in the YMRS > or = 20  IQ < 70 Pharmacologic treatment in the last month Pregnancy or absence of a contraceptive method in fertile girls Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency Risk of suicide or homicide Clinical condition that might interfere in the study Known sensibility to aripiprazole


eligible ages (years): 18.0-65.0,  All  Bipolar Disorders Aged 18-65 Minimum two year history of depressive and hypomanic episodes Mood episodes occuring monthly Meet DSM-IV for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes)  Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication History of psychotic symptoms during hypomanic or depressive episodes Current suicidal behaviours Current substantive illicit drug use or alcohol consumption Significant personality disorder Pregnancy or breastfeeding History of heart disease, liver disease, epilepsy or seizures


eligible ages (years): 25.0-55.0,  All  Insomnia Primary Insomnia Psychophysiologic Insomnia Ages 25 a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m Patients with Primary Insomnia will meet diagnostic for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD) complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months  Unstable medical or psychiatric illness Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.) symptoms suggestive of sleep disorders other than insomnia polysomnographic data indicating sleep disorders other than insomnia Evidence of active illicit substance use or fitting for alcohol abuse or dependence inadequate language comprehension pregnancy first-degree relatives with bipolar disorder or schizophrenia