[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leg-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leg-ulcer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,76,143,170,194,215,257],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100541157","phase-1-cell-therapy-for-lower-limb-ulcers-in-patients-with-critical-limb-ischemia-100541157",false,"NCT06326203","Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia","Randomized, Prospective, Controlled, Single-center, Open-label Phase II Clinical Trial Aimed at Evaluating the Safety and Efficacy of Autologous Mesenchymal Stem Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia","Inclusion Criteria:\n\n* Absence of distal pulses in the leg (anterior tibial and posterior tibial) and presence or absence of popliteal pulse.\n* Peripheral Arterial Disease (PAD).\n* Having foot or leg ulcer(s) (distal third) with a minimum area of 1cm2 and a maximum of 3 ulcers totaling up to 20cm2 in the lower limb.\n* Having previously received conventional dressing treatment for ulcer indicating no improvement over a minimum period of 3 weeks (antibiotic therapy - if necessary - local care such as mechanical, surgical or chemical debridements - if necessary, dressings).\n* PAD with IC classified as Fontaine IV and Rutherford 5.\n* Having Ankle Brachial Index (ABI) \\\u003C0.9 in infragenicular arteries (anterior tibial, posterior tibial, and fibular) or ABI\\>1.3 in one or more infragenicular arteries when suffering from chronic DMT2 (disease duration \\> 5 years) not subjected to revascularization treatment or subjected to partial revascularization treatment or treatment failure (stenosis or occlusion) in the last 12 months.\n* Inability to revascularize the affected limb (do not have visible infragenicular arteries for surgical approach) and or incomplete revascularization of this limb (undergone endovascular and or surgical treatment that was not able to restore infragenicular pulses) and defined by the doctor that the best available treatment from the surgical vascular point of view has already been performed and was not successful in promoting ulcer healing.\n* Drug treatment for PAD and for comorbidities.\n* Availability to attend medical appointments.\n\nExclusion criteria:\n\n* Being pregnant or in the puerperium.\n* Having a healed ulcer during the screening period.\n* Having signs of systemic infection or active infection in the arterial ulcer or infection of surgical prostheses (bypass, pins, screws). They may be eligible again if they have been successfully treated with antibiotics and the infectious focus has been removed.\n* Having an ulcer with devitalized tissue (necrosis). They may be eligible again if they have undergone successful surgical debridement or minor amputations (amputation of toes or limited to the forefoot).\n* Having neoplasia and\u002For being in chemotherapy or radiotherapy treatment or in remission for less than 6 months.\n* Being on colchicine or immunomodulators.\n* Having infectious diseases such as Human Immunodeficiency Virus (HIV), Hepatitis B and C viruses, Human T-cell Lymphotropic Virus (HTLV); due to the risk of contagion during the manipulation of biological material in the laboratory.\n* Having undergone amputation at the level of the leg or thigh in the limb intended to be studied.\n* Having COVID-19, diagnosed less than 4 weeks ago.","ALL","18 Years","90 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.",[28,29],"Peripheral Arterial Disease","Leg Ulcer","NOT_YET_RECRUITING","2026-05-04",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":21},"2026-06-01",{"date":38,"type":21},"2028-03-31",{"name":40,"class":41},"UPECLIN HC FM Botucatu Unesp","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100599831","phase-4-trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-ulcers-and-venous-leg-ulcers-100599831","NCT07089602","Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","BIOCAMP","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: DFU\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The target ulcer is infected or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject is taking hydroxyurea.\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.\n\n  a. eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria:VLU\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.\n\n  a. \\*eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.",{"count":51,"type":21},650,[53],"PHASE4","The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.",[56,57,58,59,60,61,29,62,63],"Diabetic Foot","DFU","Diabetic Foot Ulcer","Foot Ulcer, Diabetic","Ulcer Foot","Venous Leg Ulcer","Leg Ulcers Venous","Ulcer","RECRUITING","2025-07-24",{"date":67,"type":34},"2025-07-28",{"date":69,"type":34},"2025-07-15",{"date":71,"type":21},"2027-07",{"name":73,"class":74},"BioLab Holdings","INDUSTRY",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":107,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":75},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":85,"type":21},300000,"5 Years","OBSERVATIONAL","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[56,90,91,92,93,29,94,28,95,96,97,98,99,100,101,102,103,104,105,106],"Pressure Ulcer","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Pyoderma","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Pressure Ulcer (PU)","Diabetic Foot Ulcers (DFUs)","Pressure Injury","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[108,109,110,111,112,113,58,61,90,102,114,115,96,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Advanced Wound Care","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Debridement","Standard of Care","2025-07-10",{"date":136,"type":34},"2025-07-16",{"date":138,"type":34},"2005-01-01",{"date":140,"type":21},"2030-01",{"name":142,"class":41},"U.S. Wound Registry",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":75},"100527886","effectiveness-of-musicotherapy-in-reducing-pain-induced-by-leg-ulcer-care-100527886","NCT06153589","Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care","Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care: a Randomized, Controlled, Open-label, Parallel-arm Study","MUS-ICAT","Inclusion Criteria:\n\n* Adult patient,\n* Patient followed at the M@diCICAT healing center requiring wound debridement :\n\n  * For a venous or arterial ulcer or necrotizing angiodermatitis of the lower limbs,\n  * Having the ability to verbalize about their pain (communicating),\n  * With a planned debridement time of less than 40 minutes.\n* Patient affiliated to or beneficiary of a social security scheme,\n* Patient having given free, informed and express consent.\n\nExclusion Criteria:\n\n* Patient with a diabetic foot (loss of sensitivity-neuropathy),\n* Patient not requiring a debridement session,\n* Patient with an infected ulcer (abscess, etc.),\n* Patient with critical ischemia,\n* Patient with hearing problems,\n* Patient with cognitive disorders,\n* Patient placed under legal protection, guardianship or curatorship,\n* Pregnant or breastfeeding woman.",{"count":152,"type":21},180,[154],"NA","Venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency. The problems caused by venous disease are initially minor and often neglected, but can impact the quality of life of patients.\n\nThe prevalence of leg ulcers is estimated at 1% of the general population and 3% to 5% of subjects over 65 years old. Its prevalence increases with age in both men and women.\n\nManaging chronic ulcers requires a certain number of care procedures, including debridement.\n\nThe act of treatment by mechanical debridement is little relieved by the analgesics given beforehand, and can be painful, with risks of bleeding.\n\nMusicotherapy, particularly the U-shaped method, has shown its effectiveness in the treatment of pain and anxiety in several areas (geriatrics, intensive care, rheumatology, oncology, etc.).\n\nThe standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 (Pr. Jacques Touchon; Dr. Stéphane Guétin).\n\nFollowing the publication of numerous controlled, randomized studies presenting results on the effectiveness in the treatment of pain and anxiety, a digital application was developed in order to standardize the method. The Music Care health application is now a Class 1 Medical Device, with CE marking obtained.\n\nThis \"U-shaped sequence\" is standardized and has been clinically validated, which makes Music Care a unique tool available for pain relief.\n\nNo studies have been found in the literature regarding the use of music therapy during debridement care.",[157,29,62,158],"Debridement Care","Pain",[132,160,158],"Venous leg ulcer","2025-03-26",{"date":163,"type":34},"2025-03-31",{"date":165,"type":34},"2025-01-08",{"date":167,"type":21},"2026-09-08",{"name":169,"class":41},"University Hospital Center of Martinique",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":75},"100579595","phase-4-evaluating-several-cellular-acellular-and-matrix-like-products-camps-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-and-venous-leg-ulcers-100579595","NCT06826339","Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","Inclusion Criteria:(DFU)\n\n* Subjects The potential subject must be at least 21 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: (DFU)\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The potential subject has a disorder that would create unacceptable risk of post-operative complication.\n\nInclusion Criteria:(VLU)\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n* The potential subject has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: (VLU)\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.","21 Years",{"count":179,"type":21},340,[53],"Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.",[61,183,56,58,59,60,29,184,63],"Venous Leg","Ulcer Venous","2025-02-12",{"date":187,"type":34},"2025-02-13",{"date":189,"type":34},"2024-12-06",{"date":191,"type":21},"2027-12",{"name":193,"class":74},"Tiger Biosciences, LLC.",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":75},"100559159","modified-multi-platform-trial-assessing-multiple-camps-and-soc-vs-soc-alone-in-the-treatment-of-dfu-and-vlus-100559159","NCT06560502","Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of DFUs and VLUs.","Inclusion Criteria:\n\n* 1\\. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .\n\n  4\\. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n\n  5\\. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n\n  6\\. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.\n\n  7\\. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  a. ABI between 0.7 and ≤ 1.3; b. TBI ≥ 0.6; c. TCOM ≥ 40 mmHg; d. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n\n  9\\. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n\n  10\\. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n\n  11\\. The potential subject must agree to attend the weekly study visits required by the protocol.\n\n  12\\. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The potential subject's target ulcer is not secondary to diabetes.\n3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n4. The target ulcer exposes tendon or bone.\n5. There is evidence of osteomyelitis complicating the target ulcer.\n6. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n7. The potential subject is taking hydroxyurea .\n8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n9. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n10. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n11. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n12. The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n13. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n14. Women who are pregnant or considering becoming pregnant within the next 6 months.",{"count":202,"type":21},324,[154],"This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.",[58,61,60,29],"2025-01-16",{"date":208,"type":34},"2025-01-20",{"date":210,"type":34},"2024-08-01",{"date":212,"type":21},"2026-08",{"name":214,"class":74},"Stability Biologics",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":243,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":75},"100567960","clinical-trial-assessing-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-in-nonhealing-dfus-and-vlus-100567960","NCT06674980","Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","C5CAMP","Inclusion Criteria for DFU:\n\n1. At least 18 years of age or older.\n2. Must have diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.\n4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.\n5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n6. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n7. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and \\\u003C= 1.3\n   2. TBI \\>= 0.6\n   3. TCOM \\>= 40 mmHg\n   4. PVR: biphasic\n8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.\n10. Subject must consent to using the prescribed offloading method for the duration of the study.\n11. Subject must agree to attend weekly study visits.\n12. Subject must be willing and able to participate in the consent process.\n\nExclusion Criteria for DFU:\n\n1. Subject is known to have a life expectancy of \\\u003C 6 months.\n2. Subject's target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Target ulcer exposes tendon or bone.\n5. Evidence of osteomyelitis complicating the target ulcer.\n6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. Subject is taking hydroxyurea.\n9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.\n14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.\n16. Subject has end stage renal disease requiring dialysis.\n17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.\n20. Subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria for VLU:\n\nPotential subjects are required to meet all the following criteria for enrollment in the study.\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The potential subject must agree to attend the weekly study visits required by the protocol.\n8. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria for VLU:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n3. The target ulcer exposes tendon or bone.\n4. There is evidence of osteomyelitis complicating the target ulcer.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n9. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. Women who are pregnant or considering becoming pregnant within the next 6 months.\n11. The potential subject has end stage renal disease requiring dialysis.\n12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n14. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n15. The subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n16. A subject has a wound with active or latent infection is excluded.\n17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":224,"type":21},177,[154],"The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.",[228,229,230,231,232,233,234,235,29,93,236,237,238,239,56,240,241,63,242],"Pathologic Processes","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Disease","Diabetic Angiopathies","Vascular Diseases","Cardiovascular Diseases","Skin Diseases","Diabetes Complications","Diabetic Neuropathies","Foot Diseases","Foot Ulcer","Diabetes Mellitus, Type 2","Foot Ulcer Unhealed",[244,245,246,247,248],"Human Placental Membrane (HPM)","Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Cellular, Acellular, and Matrix-like Product (CAMP)","Cellular and\u002For Tissue-Based Product (CTP)","2024-12-20",{"date":251,"type":34},"2024-12-27",{"date":249,"type":34},{"date":254,"type":21},"2027-01-22",{"name":256,"class":74},"C5 Biomedical",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":75},"100462602","phase-4-topical-sevoflurane-for-treatment-of-chronic-leg-ulcers-100462602","NCT05303805","Topical Sevoflurane for Treatment of Chronic Leg Ulcers","Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers","Inclusion Criteria:\n\n* Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS\\>4) non- healing tibial venous ulcers\n\nExclusion Criteria:\n\n* Allergy to sevoflurane\n* Inability to understand the pain-intensity questionnaire",{"count":265,"type":21},50,[53],"Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml\u002Fcm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early.\n\nExclusion criteria: allergy to sevoflurane, inability to understand the questionnaire\n\nParameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect",[29],[29,270,158,271,272],"Sevoflurane","Healing ulcer","Microbial colonization","2024-08-24",{"date":275,"type":34},"2024-08-27",{"date":277,"type":34},"2022-05-02",{"date":279,"type":21},"2027-01-31",{"name":281,"class":41},"Charles University, Czech Republic"]