[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-leg-ulcer-vlu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-leg-ulcer-vlu":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,53,77,111,141,164,193,227,252,278,302,325,351,383,406,438,458],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100605490","smart-bandage-with-telemonitoring-vs-standard-care-for-venous-leg-ulcer-randomized-trial-100605490",false,"NCT07163195","Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial","Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial","SMART-VLU","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Clinically diagnosed venous leg ulcer persisting for more than 3 weeks\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\>65 years (elderly patients excluded)\n* Acute or emergency wounds\n* Mixed etiology ulcers with significant arterial involvement\n* Severe comorbid illness such as end-stage renal failure or active malignancy\n* Cognitive impairment preventing informed consent\n* Allergy to dressing materials","ALL","18 Years","65 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"NA","Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new \"smart bandage\" that can monitor wound conditions such as pH, temperature, and moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time.\n\nThe purpose of this randomized controlled trial is to compare smart bandage plus standard wound care with standard wound care alone. We will assess whether the smart bandage improves healing rates within 12 weeks, shortens time to healing, reduces infection, and improves quality of life in patients with VLUs. About 110 adult participants with VLUs will be enrolled at Clinic Podiatry Care, Purwokerto, Indonesia.",[28,29],"Venous Leg Ulcer (VLU)","Chronic Wound",[31,29,32,33,34,35,36,37,38,39],"Venous Leg Ulcer","Smart Bandage","Telemonitoring","Digital Health","Mobile Application","Wound Care","Wound Healing","Randomized Controlled Trial","Indonesia","NOT_YET_RECRUITING","2026-06-03",{"date":43,"type":44},"2026-06-04","ACTUAL",{"date":46,"type":22},"2026-07-26",{"date":48,"type":22},"2027-01-27",{"name":50,"class":51},"Asmat Burhan","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100640508","a-randomized-non-inferiority-study-of-mepi-press-2-vs-urgok2-for-compression-therapy-in-venous-leg-ulcers-100640508","NCT07600489","A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers","A Comparative, Adaptive, Randomized, Non-Inferiority Clinical Investigation of Two-Layer Compression Bandages Mepi™ Press 2 Versus UrgoK2® in the Treatment of Venous Leg Ulcers","Inclusion Criteria:\n\n* Patients ≥ 18 years.\n* Stage C6 venous leg ulcer diagnosed less than 24 months ago.\n* 2cm² ≤ VLU surface area ≤ 40cm².\n* ABPI equal or higher than 0.8 and equal or lower than 1.3.\n* Able to read, understand and speak French for their medical care.\n* Agreeing to follow the procedures described in the CIP.\n* Benefiting from a social insurance coverage.\n\nExclusion Criteria:\n\n* Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.\n* Planned endovenous treatment or surgical venous stripping \u002F exeresis within 8 weeks before planned inclusion date, or before end of participation to the study.\n* Treatment with chemotherapy or antineoplastic agent within the last 6 months.\n* Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings.\n* Pregnant or breastfeeding women.\n* Persons deprived from their liberty.\n* Persons protected under guardianship or curatorship.\n* Any person who, as per investigator's decision, is not suitable to participate in the investigation for any other reason.-",{"count":61,"type":22},386,[25],"Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs.\n\nThe goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients.\n\nThe main question it aims to answer is:\n\n-Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks?\n\nResearchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved.\n\nParticipants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants.\n\nParticipants will:\n\n* Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care\n* Receive an appropriate primary wound dressing prior to compression\n* Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first)\n* Be assessed for wound healing, safety, and device performance throughout the study",[28,65],"Compression Bandages","2026-05-13",{"date":68,"type":44},"2026-05-20",{"date":70,"type":22},"2026-05",{"date":72,"type":22},"2028-05",{"name":74,"class":75},"Molnlycke Health Care AB","INDUSTRY",8,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":52},"100602421","effect-of-photobiomodulation-on-healing-of-venous-leg-ulcers-100602421","NCT07123285","Effect of Photobiomodulation on Healing of Venous Leg Ulcers","Effect of Photobiomodulation on the Healing of Venous Ulcers in the Lower Limbs","Inclusion Criteria:\n\n* Patients of both sexes;\n* Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;\n* Age between 18 and 85 years;\n* Residents of Lençóis Paulista or nearby regions.\n\nExclusion Criteria:\n\n* Patients with ulcers of non-venous etiology;\n* Pregnant women;\n* Presence of severe arterial disease in the lower limbs.","85 Years",{"count":86,"type":22},96,[25],"This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 96 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p \\\u003C 0.05.",[90,91,92,28,31,93,94,95],"Venous Disease","Venous Insufficiency (Chronic)(Peripheral)","Venous Insufficiency of Leg","Venous Hypertension Ulcers","Varicose Ulcers","Varicose Ulcer of Lower Limb",[97,98,99,100,101,102],"venous ulcers","varicose ulcers","photobiomodulation","lasers","phototherapy","venous leg ulcer","2026-04-27",{"date":105,"type":44},"2026-04-29",{"date":70,"type":22},{"date":108,"type":22},"2027-07",{"name":110,"class":51},"University of Nove de Julho",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100559783","phase-3-a-double-blind-study-performed-to-evaluate-the-efficacy-and-the-safety-of-escharex-in-debridement-of-vlu-value-100559783","NCT06568627","A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)","A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)","VALUE","Inclusion Criteria:\n\n1. Men or women, older than 18 years of age,\n2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),\n3. Wound is present for at least 4 weeks but no longer than 1 year,\n4. The adherent necrotic\u002Fthick slough\u002Ffibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),\n5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),\n6. Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure.\n\nExclusion Criteria:\n\n1. Wound size that has decreased by \\> 20% after 7 (+3\u002F-1) days of the screening period,\n2. Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,\n3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,\n4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \\>2 cm around the wound's edge,\n5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,\n6. Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,\n7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,\n8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,\n9. Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,\n10. Patients with primary lymphatic edema (Lymphedema),\n11. A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms,\n12. Patients with pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e., pseudoeschar as a result of SSD treatment),\n13. History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,\n14. Patients with poor nutritional status: albumin \\\u003C 2.5 g\u002Fdl; poorly controlled diabetes mellitus (HbA1c \\> 12%); anemia (hemoglobin\\\u003C8 g\u002FdL), leukocyte count \\\u003C 3,000\u002Fμl or \\>15000\u002Fμl; neutrophil count ≤1000\u002Fμl; platelets \\\u003C100,000\u002Fμl, abnormal liver function (AST, ALT\\>2 x upper limit of normal range), renal failure (Cr \\> 2.5 mg\u002Fdl or eGFR \\\u003C 30ml\u002Fmin \u002F1.73m2), BMI\\>48,\n15. INR\\>2 or PTT \\> x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),\n16. Patients undergoing renal or peritoneal dialysis,\n17. Any condition that would preclude safe participation in the study, e.g., significant or unstable cardiac, vascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19 or any immediate life-threatening condition,\n18. Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,\n19. The patient is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing processes. These include chronic systemic steroid intake5 associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or a history of laceration), immuno-suppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly,\n20. Patients treated with Pentoxifylline within 2 weeks prior to screening,\n21. Venous ablation performed within the past month in an area adjacent to the target wound,\n22. Mentally incapacitated incompetent adults who are incapable of giving legal consent (e.g., dementia, psychiatric patients, etc.),\n23. Concurrent use of non-approved drugs or alcohol abuse,\n24. Pregnant women (positive pregnancy test) or nursing mothers,\n25. Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.",{"count":120,"type":22},216,[122],"PHASE3","The main objective of this study is:\n\nTo assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).",[28],[126,127,128,129],"VLU","EscharEx","Debridement","Wound bed preparation","RECRUITING","2026-03-27",{"date":133,"type":44},"2026-04-02",{"date":135,"type":44},"2025-06-01",{"date":137,"type":22},"2027-03",{"name":139,"class":75},"MediWound Ltd",25,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":162,"locationsCount":52},"100626835","evaluation-of-the-efficacy-and-tolerance-of-vashe-solution-versus-saline-solution-in-the-treatment-of-venous-or-mixed-leg-ulcers-presenting-inflammatory-signs-suggesting-heavy-bacterial-load-100626835","NCT07440797","EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD","EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD: MULTICENTER, PROSPECTIVE, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Adult patient, at least 18 years of age or older who has provided free, written, and informed consent,\n* Patient who has already worn compression therapy in the past and agrees to wear the two-layer compression system during the whole treatment period,\n* Patient presenting a venous or mixed leg ulcer predominantly of venous origin (ABPI between ≥0.8≤1.3,\n* Leg ulcer presenting at least 3 inflammatory signs (e.g pain, erythema...)\n* Target leg ulcer located at least 3 cm from the edge of another wound.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient,\n* Patient already participating in another clinical trial, except observational trial\n* Patient with epifascial arterial bypass (superficial arterial bypass)\n* Patient suffering from phlegmatia coerulea dolens, septic phlebitis, acute deep vein thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.\n* Patient receiving or having received systemic antibiotics within the ten days prior to inclusion in the investigation, regardless of therapeutic class or indication,\n* Cancerous wound.",{"count":149,"type":22},102,[25],"Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load",[28],[102,154,155],"inflammatory signs","chronic wound","2026-03-02",{"date":158,"type":44},"2026-03-04",{"date":160,"type":22},"2026-03",{"date":137,"type":22},{"name":163,"class":75},"Laboratoires URGO",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100621787","evaluation-of-the-safety-and-efficacy-of-dehydrated-human-placenta-tissue-dhpt-for-wound-healing-100621787","NCT07375160","Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","RETRO-PLAST","Inclusion Criteria:\n\n* 18 years of age or older.\n* Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).\n* Wound present for greater than or equal to 30 days prior to treatment with dHPT.\n* Wound is not infected.\n* Wound surface area is greater than 1cm2 at initial assessment.\n* Clinical documentation of wound treatment.\n\nExclusion Criteria:\n\n* AmchoPlast dHPT product was not applied to wound.\n* HbA1C \\>12%.\n* Presence of active osteomyelitis.\n* Concurrent treatment for malignant disease.\n* Use of other advanced biologics during treatment period.",{"count":173,"type":22},300,"OBSERVATIONAL","The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.",[177,28,178],"Diabetic Foot Ulcer (DFU)","Pressure Ulcer (PU)",[29,180,181,182,183],"Leg Wound","Amniotic","Allograft","Placenta","2026-02-27",{"date":186,"type":44},"2026-03-03",{"date":188,"type":22},"2026-04",{"date":190,"type":22},"2026-12",{"name":192,"class":75},"Cellution Biologics",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":204,"conditions":205,"keywords":213,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":52},"100620977","phase-4-a-multicenter-prospective-controlled-modified-multi-platform-trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-in-the-management-of-nonhealing-diabetic-foot-ulcers-and-venous-leg-ulcers-100620977","NCT07364630","A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","BIORESCUE","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* If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study.\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* The potential subject must have participated in the BIOCAMP trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.\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 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 TV-1.\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 TV-1.\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, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject did not participate in the BIOCAMP trial.\n* The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm.\n* The potential subject participated in the BIOCAMP trial and achieved complete closure.\n* The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.",{"count":201,"type":22},50,[203],"PHASE4","The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.",[206,207,208,209,28,31,210,211,212],"Diabetic Foot Ulcer","Foot Ulcer Chronic","DFU","Ulcer Foot","Venous Ulcer","Leg Ulcers","Ulcer",[214,212,210,215,126,208,206,216,217],"Leg Ulcer","Venous Leg ulcer","Foot Ulcer","Diabetic foot","2026-02-05",{"date":220,"type":44},"2026-02-09",{"date":222,"type":44},"2026-01-02",{"date":224,"type":22},"2027-01",{"name":226,"class":75},"BioLab Holdings",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100619240","convavac-ag-negative-pressure-wound-therapy-system-in-chronic-wounds-100619240","NCT07342049","ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds","A Study to Determine the Safety and Performance of ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds","ConvaVAC VLU","Inclusion Criteria:\n\n* A wound which is amenable to NPWT and is a VLU as defined by CEAP Classification of C6 or C6R\n* Wounds that are clean or contaminated\n* Wounds with at least one sign or symptom of infection\n* Wounds that in the opinion of the investigator would benefit from an antimicrobial dressing\n* ≥18 years old at the time of consent\n\nExclusion Criteria:\n\n* Known sensitivities or allergies to components of the ConvaVAC™ Ag+ NPWT System\n* Ischemic wounds with necrotic tissue or eschar present that require sharp debridement\n* Wound is too small or too large based on wound dressing size (\\> 0.5cm2 and \\\u003C 100cm2)\n* Wound depth \\>7cm\n* Wounds requiring concomitant use of DuoDERM® gel, hydrogels, petroleum-based creams\u002F ointment-\u002Fgels per the opinion of the investigator\n* Active chemotherapy, radiation therapy, or immunotherapy for cancer or completed treatment within the last 3 months\n* Any active malignancy at site of dressing application\n* Exposed bone in target wound\n* Exposed blood vessels or nerves in target wound\n* Systemic infection and\u002For systemic inflammatory response syndrome (SIRS), sepsis\n* Cellulitis in target wound\n* Untreated deep tissue infection including but not limited to osteomyelitis, septic arthritis\n* Active Pregnancy\n* Subjects that in the opinion of the investigator are not suitable for enrollment\n* Vulnerable subjects as determined by ICH Harmonized Guideline, Good Clinical Practice E6(R2)",{"count":236,"type":22},87,[25],"Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds. In this study, the focus is on Venous Leg Ulcers (VLUs). Chronic wounds are wounds that do not heal properly or take a long time to heal. They can cause pain, discomfort, and affect your day-to-day life. These types of wounds are also challenging for healthcare teams to treat and can take up a lot of healthcare resources. Venous Leg Ulcers (VLUs) are the most common type of chronic leg wound and affect about 1 in every 100 people. Usual treatments for VLUs include cleaning the wound, using special dressings, applying pressure (compression therapy), and sometimes using creams or dressings that contain silver to fight infection. This study is being done to see if the wound therapy system can help heal venous leg ulcers more effectively and safely.",[28],[31,241,242],"Negative Pressure Wound Therapy","Silver ions","2026-01-28",{"date":245,"type":44},"2026-01-29",{"date":247,"type":22},"2026-01-12",{"date":249,"type":22},"2026-10-01",{"name":251,"class":75},"ConvaTec Inc.",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100606233","phase-4-a-non-randomized-open-label-clinical-trial-evaluating-dermabind-tl-100606233","NCT07172893","A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL","A Non-Randomized Open Label Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of DermaBind TL, a Placental Membrane Allograft Intended for Use in the Management of Non-Healing Ulcers","Inclusion Criteria:\n\n* 1\\. Be an adult between 18 and 80 years of age at the time of consent 2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix A for definitions) on the plantar, lateral or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.\n\n  3\\. Subjects must have a diagnosis of Type I or Type II diabetes mellitus (DM) as defined by the American Diabetes Association\n  1. for Type I DM, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit, or\n  2. for Type II DM, must have been on a stable anti-diabetic medication for at least 30 days, or if diet-controlled only, must have been on stable diet-control for at least 6 months.\n\n     4\\. For Type I and Type II DM, A1C must be equal or \\\u003C10% in the last 30 days, or confirmed during the screening period (SV1 up to TV1) 5. Have a single target ulcer 6. If other DFU wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \\[NOTE: If two or more DFUs are present with the same grade on the same foot, the index ulcer is the largest ulcer and the only one evaluated in the study.\\] 7. Have a wound with an area greater than 1cm2 and less than 25 cm2 and does not probe to bone 8. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.\n\n     9\\. Index ulcer must be a DFU with a Wagner Grade of 1 or 2. 10. Have an absence of infection based on the Infectious Disease Society of America criteria and as evidenced by radiographic evidence (X-ray, CT or MRI scan) performed during the 14 Screening Period (SV1-TV1). Radiological evidence must be completed, resulted and confirmed by the treating study physician prior to application of study graft to index ulcer.\n\n     11\\. Have adequate circulation to the affected lower extremity confirmed during the screening period, defined as at least one of these criteria:\n\n  \u003C!-- -->\n\n  1. TCOM ≥30 mmHg\n  2. ABI between 0.7 and 1.3\n  3. SPP \\>30 mmHg\n  4. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.\n\n     12\\. Have the ability to comply with protocol defined off-loading to the index ulcer and dressing change requirements 13. Patient is a non-tobacco user, including all forms of nicotine delivery (e.g., cigarettes, cigars, pipes, vaping devices, smokeless tobacco or nicotine patch) for a minimum of 4 weeks prior to the initial application of study graft. Verbal confirmation by subject is acceptable.\n\n     14\\. Have the ability to understand the requirements of the study and to give informed consent 15. Have a life expectancy of greater than 6 months 16. Have failed conservative wound care treatment of the index ulcer for at least of 4 weeks 17. Patient will not require negative pressure therapy to the index ulcer, antimicrobial dressings, hyperbaric oxygen therapy to the index ulcer during the study period.\n\n     18\\. Patient has not had radiation to the index ulcer site. 19. The index ulcer has a clean base, free of necrotic debris and infection at time of placement of treatment product.\n\n     20\\. The index ulcer has been off-loaded, per protocol requirements, with a CAM boot (Foot Defender®) or TCC for a minimum of 14 days (+3 days) following SV1.\n\n     21\\. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests at various timepoints during study participation.\n\n     Exclusion Criteria:\n* 1\\. Pregnant or lactating 2. Less than 18 years of age 3. Has continued tobacco use 4. Have a wound that decreased in size ≥30% between the Screening and Treatment Visits 5. Wound is showing signs of healing and that improvement is likely to continue without treatment (increased granulation, epithelization, decrease in size ≥ 30% reduction in wound surface area).\n\n  6\\. Circulating hemoglobin A1c exceeding 10% within 30 days of the Screening Visit 7. Serum creatinine concentrations of 3.0 mg\u002FdL or greater within 30 days prior to screening 8. The wound has been treated with biomedical or topical growth factors within the previous 30 days before the screening visit 9. Need for any additional concomitant dressing material other than the ones approved for this study 10. Osteomyelitis or bone infection of the affected foot as verified by x-ray or other radiographic modality within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n  11\\. The inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast) 12. Have a known or suspected disease of the immune system 13. Have an active or untreated malignancy or active, uncontrolled connective tissue disease 14. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.\n\n  15\\. At the index ulcer site, presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement 16. Had undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit 17. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening 18. Uncontrolled edema, lymphedema or venous HTN in the limb of the index ulcer 19. Undergone treatment to the index ulcer with a living skin equivalent within the last 4 weeks before screening 20. Undergone treatment to the index ulcer with a placental-derived allograft within the last 4 weeks before screening 21. Has the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated 22. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.\n\n  23\\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.\n\n  24\\. Subjects with a previous diagnosis of HIV or Hepatitis C, regardless of current status .","80 Years",{"count":261,"type":22},150,[203],"The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.",[177,28],[266,206,31,267],"Placental allograft","DermaBind TL","2025-12-22",{"date":270,"type":44},"2025-12-23",{"date":272,"type":44},"2025-12-10",{"date":274,"type":22},"2027-05-21",{"name":276,"class":75},"HealthTech Wound Care",10,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100610650","phase-4-nonhealing-venous-leg-ulcers-treated-with-a-standard-of-care-soc-alone-or-standard-of-care-and-dehydrated-human-placenta-tissue-dhpt-with-crossover-100610650","NCT07230340","Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover","A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers With Crossover for Subjects Randomized to Standard of Care","EVOLVE","Inclusion Criteria:\n\nParticipants are required to meet all the following criteria for enrollment into the study:\n\n1. 18 years of age or older.\n2. Hemoglobin A1c (HbA1c) level is \\\u003C12% (108 mmol\u002Fmol).\n3. Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.\n4. Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.\n5. Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods are acceptable:\n\n   1. ABI ≥ 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic or triphasic.\n6. If the participant 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 participant must agree to attend the weekly study visits required by the protocol.\n8. The participant must be willing and able to participate in the informed consent process\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from enrollment:\n\n1. Known life expectancy of \\\u003C6 months.\n2. Target ulcer is infected or there is cellulitis in the surrounding skin.\n3. Evidence of osteomyelitis complicating the target ulcer.\n4. Participant requires systemic antibiotic therapy or has used within the last 7 days.\n5. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent), receiving cytotoxic chemotherapy, or taking medications that the investigator believes will interfere with wound healing (e.g., biologics).\n6. Topical application of steroids to the ulcer surface within 30 days of screening.\n7. Target ulcer exposes tendon or bone.\n8. Surface area of the target ulcer decreases by more than 20% during the 2-week screening phase.\n9. Mini Nutritional Assessment (MNA) score of less than 17.\n10. Participants of child bearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n11. Currently requiring dialysis or planning to start within 6 months.\n12. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n13. Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.\n14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.",{"count":287,"type":22},70,[203],"The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.",[28],[126,210,180,292,181,183,293],"Venous Leg Ulcers (VLUs)","allograft","2025-12-09",{"date":296,"type":44},"2025-12-16",{"date":298,"type":22},"2026-01",{"date":300,"type":22},"2027-12",{"name":192,"class":75},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":52},"100613583","assessing-sensor-guided-compression-therapy-for-venous-leg-ulcers-healing-outcomes-100613583","NCT07268482","Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes","Randomised Control Study of Using a Pressure Monitoring Technology for Improving the Targeted Application, Monitoring, and Maintenance of Compression Therapy in Patients With Venous Leg Ulcers","Inclusion Criteria:\n\n* Adults with chronic venous leg ulcers (≥6-week and ≤5-year durations) currently in compression therapy treatment.\n* Between 5 and 100 cm2 wound area at randomization.\n* Ankle brachial pressure index (ABPI) of \\>0,8\n* Capable of using use a smart device.\n\nExclusion Criteria:\n\n* Uncontrolled diabetes \\[haemoglobin A1c (HbA1c) ≥12% in the last 3 months\\]\n* Index ulcer has active infection on day of inclusion requiring systemic antibiotic therapy\n* Renal failure\n* Exposed tendon, ligament, muscle or bone in the index ulcer\n* Osteomyelitis, cellulitis or gangrene in study limb\n* Subjects with an amputation above transmetatarsal in study limb\n* Active malignancy affecting study limb\n* Index ulcer is of arterial aetiology (ABPI \\\u003C0.8)\n* Pregnant or breast-feeding women or women of childbearing potential not willing to use a method of highly effective contraception for the duration of the study\n* Planned vascular surgery, angioplasty or thrombolysis procedures during study period. Or patients who are within six weeks of having had such a procedure\n* Planned surgical procedure during study period for the index wound\n* Prior skin replacement, negative-pressure therapy and ultrasound therapy to the study wound in the two weeks before screening\n* Currently receiving or has received radio or chemotherapy within three months of randomisation\n* Index wound would require ultrasound near an electronic implant or prosthesis\n* Not capable of providing informed consent\n* Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days",{"count":310,"type":22},40,[25],"The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU). Venous leg ulcers are wounds on the lower leg that need compression bandages to help them heal.\n\nIn this study, patients will be randomly placed into one of two groups:\n\n* Group 1: Will receive the usual care for VLUs.\n* Group 2: Will use a new connected health system, called Tight Alright, along with their usual care.\n\nThe Tight Alright system includes a small, wearable device that sits under a patient's bandage. This device measures the pressure at three points on the patient's lower leg and sends the information wirelessly to a mobile app. The app shows real-time pressure readings and also sends the data to a secure cloud database. This allows the patient's healthcare team to monitor their bandage pressure remotely and make sure it is just right.\n\nThe aim is to help nurses and doctors apply the correct pressure every time, which is important for healing. The system can also alert the patient's healthcare team if the pressure drops, so they can decide if a patient's bandage needs adjusting, even when the patient is at home.\n\nThe investigators will follow all participants for 90 days and then compare how well the ulcers have healed in both groups. This will help us find out if the new system can improve healing and make treatment safer and more effective.",[28],[315],"Venous Leg Ulcers","2025-11-25",{"date":318,"type":44},"2025-12-05",{"date":320,"type":22},"2026-01-15",{"date":322,"type":22},"2026-10-30",{"name":324,"class":75},"Feeltect Limited",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":52},"100574088","phase-4-trial-to-evaluate-cyclical-topical-wound-oxygen-therapy-in-the-treatment-of-chronic-venous-leg-ulcers-100574088","NCT06754735","Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers","A Multi-national, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Venous Leg Ulcers","VaLUe I","Inclusion Criteria:\n\n* Adults ≥ 18 years and able to provide written informed consent\n* Patients who have a chronic venous leg ulcer (VLU) below the knee at or above the malleolus determined to be due to underlying venous disease\n* Venous reflux ≥ 500 mil sec\u002Fsuperficial or 1 sec\u002Fdeep or venous mapping after interventions following a vascular procedure\n* VLU of ≥ 1.5cm2 and ≤ 50cm2 after debridement at study enrolment i.e. Screening visit\n* \\*Cluster wounds where the sum of the full thickness ulcer area must be ≤ 50cm2\n* Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry\n* The index ulcer has been treated with CCD of at least 30mmHg for ≥ 6 weeks prior to screening.\n* Adequate perfusion with Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry AND TcpO2 \\> 30mmHg OR Biphasic arterial duplex below the knee OR Toe pressure \\> 30mmHg OR TBI .6\n* Wound size reduction in a 2-week run-in period of ≤ 30%\n* Subject understands and is willing to participate in the clinical study and comply with weekly visits and follow up regime\n* Subject has read and signed IRB\u002FEC approved ICF before screening procedures commence\n\nExclusion Criteria:\n\n* • Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy\n\n  * Acute thrombophlebitis or Deep Vein Thrombosis (DVT) and within three months preceding study entry\n  * Subject awaiting venous ablation or is less than 30 days post ablation\n  * Surgery during three months prior to study entry (such as abdominal, gynecological, hip or knee replacement)\n  * Wound etiology of uncertain origin or history or prior diagnosis of Systemic Lupus Erythematosus, Burger's Disease, Pyoderma Gangrenosum or other inflammatory ulceration, vasculitis\n  * Documented evidence of osteomyelitis on any part of affected limb\n  * Index ulcer has exposed bone, muscle and tendon\n  * Index ulcer exhibits signs of unmanaged wound infection or severe clinical infection that requires hospitalization or immediate surgical intervention\n  * BMI \\> 45\n  * Uncontrolled diabetes: HbA1c \\> 12% within 60 days of screening\n  * Renal dialysis or of screening EGFR less than 30 mg\u002Fdl\n  * NYHA Class IV\n  * Peripheral arterial reconstruction\u002Frevascularization on the affected limb within the last 30 days\n  * Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids \\> 10mg daily dose, immunosuppressive agents).\n  * Active systemic treatment for malignancy\n  * History of radiation at the ulcer site\n  * Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayer cell therapy, dermal substitute, extracellular matrix) within 14 days before screening\n  * Subject participated in another investigational device, drug or biological trial within four weeks prior to study entry\n  * Subject may not be pregnant or breastfeeding at the time of treatment",{"count":334,"type":22},212,[203],"The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. Following a 2-week run-in period with SOC and after meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio with TWO2 therapy or sham control therapy plus SOC. Participants will enter the intervention period of up to 16-weeks, followed by a long-term follow-up period of 52 weeks post randomization.",[28],[339,340,341],"Ulcer, Wound, Randomized, Oxygen, Placebo, Sham, Venous, Compression","Varicose Veins, Venous stasis ulcer","Topical Oxygen","2025-11-17",{"date":344,"type":44},"2025-11-19",{"date":346,"type":44},"2025-01-15",{"date":348,"type":22},"2028-06",{"name":350,"class":75},"AOTI Ltd.",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":360,"conditions":361,"keywords":365,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100577474","reducing-skin-tone-inequities-in-chronic-venous-insufficiency-100577474","NCT06798766","Reducing Skin Tone Inequities in Chronic Venous Insufficiency","Reducing Health Inequities Through Improved Guidance and Assessment on the Early Identification of Skin Changes Associated With Chronic Venous Insufficiency (CVI) in People With Dark Skin Tones","Work-package 1 - Mapping patient journeys and patient experiences Participant inclusion criteria\n\n* people with chronic venous insufficiency, or their close family member\n* the person with chronic venous insufficiency has a dark skin tone (from Ho and Robinson skin tone range 2b-6b, table 1).\n* ability to give informed consent Participant exclusion criteria\n* person with chronic venous insufficiency has a light skin tone (from Ho and Robinson skin tone range 1a-2a, table 1).\n* people unable to speak and understand English\n* people unable to give informed consent.\n\nWork package 2 - Informing skin assessment technique and medical photography Participant inclusion criteria\n\n* people diagnosed with chronic venous insufficiency at NHS trust\n* people with a dark skin tones (from Ho and Robinson skin tone range 2b-6b, table 1).\n* ability to give informed consent\n* either coming back to the hospital for surgery or being able to travel back to the hospital to undergo physical assessment and skin photography prior to any intervention.\n* have duplex ultra-sound scan informing clinical diagnosis of venous disease. Participant exclusion criteria\n* person with chronic venous insufficiency has a light skin tones (from Ho and Robinson skin tone range 1a-2a, table 1).\n* people unable to speak and understand English\n* people unable to give informed consent.",{"count":359,"type":22},51,"The aim of this project is to define assessment criteria for chronic venous insufficiency (CVI) in people with dark skin tones. It will inform future interventions and modifications to practice for the assessment of CVI in people with dark skin tones in a nurse led intervention to improve patient assessment.\n\nTo achieve this there will be two parts to this study.\n\n1. We will explore patient journeys and patient experiences of people with dark skin tones diagnosed with chronic venous insufficiency. From this we will learn from people with dark skin tones about how they recognised skin changes in their lower legs to further inform clinical assessment guidance and techniques. We will also listen to their patient journey to identify what areas worked well and what could be developed. This will help us plan how care could be improved for similar people.\n2. We will record how skin changes look and feel in people with dark skin tones and known venous disease, and photograph this. We will consider whether some additional techniques used in practice to look and feel the skin is useful and whether changing the colour balance and manipulating the photographs is useful to see these skin changes.",[362,363,364,28],"Chronic Venous Insufficiency, CVI","Chronic Venous Insufficiency C2 or Higher","Chronic Venous Disease of Lower Limbs",[366,367,368,369,370,371,372,373],"health inequities","skin tone inequities","health equality","skin tone equality","skin assessment","physical examination","patient journey","patient experience","2025-09-09",{"date":376,"type":44},"2025-09-16",{"date":135,"type":44},{"date":379,"type":22},"2026-04-30",{"name":381,"class":51},"King's College London",2,{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":52},"100596637","phase-1-safety-and-preliminary-efficacy-of-trophipatch-an-adipose-derived-stromal-cell-patch-for-chronic-leg-ulcers-100596637","NCT07048054","Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers","Allogenic Adipose-derived Stromal Cell Patch (i.e TrophiPatch, Provided by HekeTiss®) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy, a One-arm Monocentric Phase I-ll Trial","RESCUE-PATCH","Inclusion Criteria\n\n* Age 18 years or older.\n* Patients with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.\n* Participants will have the capacity to understand study procedures, and will be able to providewritten informed consent.\n\n(for VLU only)\n\n* Diagnosed with at least one venous leg ulcer.\n* Ulcers duration for 6 weeks to 3 years at the time of screening.\n* Hard-to-healed ulcers with cross-sectional area that have decreased by less than 40% during a four-week run-in period.\n* Reference ulcer surface from 5 to 25 cm2.\n* At the time of inclusion, the ulcer will be clinically non-infected (TILI score ≥ 5).\n* Absence of significant arterial insufficiency assessed at clinical examination (intermittent claudication or resting pain, necrotic or distal wound on the foot) and systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.\n\n(for DFU only)\n\n* Patient with type 1 or type 2 diabetes.\n* Diagnosed with at least one diabetic foot ulcer on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.\n* Ulcers duration for 4 weeks to 3 years at the time of screening.\n* Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four-week run-in period.\n* Reference ulcer surface from 1 to 25 cm2.\n* At the inclusion, the ulcer will be clinically non-infected (according to IDSA criteria).\n* HbA1C \\\u003C 12% at screening.\n* Absence of significant arterial insufficiency assessed by systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.\n\nExclusion Criteria\n\n* Subject has a history of:\n\n  * endstage renal disease\n  * uncontrolled cardiac failure\n  * severe malnutrition\n  * severe liver disease\n  * aplastic anemia\n  * malignant disease (active or recent (\\\u003C5 years))diabetes avec HbA1C \\> 12%\n  * rheumatoid arthritis\n  * sickle cell disease\n  * other connective tissue disorder\n  * irradiation to the affected extremity\n* Serum creatinine concentration greater than 180 umol\u002FL and\u002For receipt of renal dialysis or an estimated glomerular filtration rate (based on cystatin C or serum creatinine) of less than 20 mL\u002Fmin per 1·73 m²\n* Drug or alcohol abuse.\n* Limited physical capacity or total immobility.\n* Known pregnancy or nursing at the time of screening visit\n* Subject is currently receiving (i.e within 30 days prior to inclusion) or scheduled to receive a medication or treatment that, in the opinion of the investigator, will interfere with or affect the rate of wound healing.\n* Index ulcers probing to tendon, muscle, capsule and bone.\n* Local or systemic signs of ongoing infection.\n* Hypersensitivity to silicone or porcine gelatin.\n* Previous treatment with growth factors, stem cells, or an equivalent preparation within the 8 weeks before the baseline visit.\n* Involvement in another interventional clinical trial within the 4 weeks before the baseline visit.\n* Known or suspected absence of capacity to understand the study procedures or provide written informed consent (decided by the investigator).\n* Cross-sectional area of the index ulcer had increased by at least 20%.\n\n(for VLU only)\n\n* History of poor compliance with compression therapy.\n* Presence of peripheral neuropathy of the lower limbs.\n\n(for DFU only)\n\n• History of poor compliance with offloading therapy.",{"count":392,"type":22},18,[394,395],"PHASE1","PHASE2","This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies.\n\nAll 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.",[177,28],"2025-06-24",{"date":400,"type":44},"2025-07-02",{"date":402,"type":22},"2025-07",{"date":190,"type":22},{"name":405,"class":51},"Nicolò Brembilla",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":4},"100590179","evaluation-of-cold-plasma-in-chronic-wound-healing-100590179","NCT06964048","Evaluation of Cold Plasma in Chronic Wound Healing","Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.","PLASANAGENESIS","Inclusion Criteria:\n\n* Adult patient, age ≥ 18 years,\n* Patients affiliated with a social security system or benefiting from such a system,\n* Patients able and willing to provide written informed consent,\n* Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures,\n* Patients whose home healthcare professional is willing to follow the clinical investigation protocol,\n* Patient with gas conformed stockage area (ventilated or at least 7m²)\n* Patients without infection, or with a local controlled infection,\n* Patients with VLU:\n\n  * Patients with wound anteriority between 1 to 12 months\n  * Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8)\n  * Patients with VLU between 4 to 30 cm² in surface area,\n  * Patients with only one VLU,\n  * Patients who have not shown wound healing improvement after wearing compression system for at least two weeks\n* Patients with DFU:\n\n  * Patients with wound duration between 1 to 12 months\n  * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7\n  * Patients with DFU between 1 to 30 cm² in surface area,\n  * Patients with only one DFU, not between toes,\n  * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks,\n* Patient with PU:\n\n  * Patient with wound duration between 1 to 12 months\n  * Patient with PU stage 2 or 3 NPUAP grade,\n  * Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and\u002For Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot\n  * Patient with PU between 4 to 30 cm² in surface area,\n  * Patient with only one PU\n  * Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly,\n\nExclusion Criteria:\n\n* Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.\n* Patients with an active Charcot's neuro-arthropathy as determined by clinical and\u002For radiographic examination,\n* Patients with critical limb ischemia or severe PAD (ankle pressure \\\u003C 50 mmHg or Toe pressure \\\u003C 30 mmHg).\n* Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.\n* Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,\n* Patients with non-controlled systemic infection by a suitable antibiotic,\n* Patients with suspicion of severe malnutrition,\n* Pregnancy or breastfeeding woman, or susceptible to be pregnant,\n* Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,\n* Patients included in another study,\n* Patients under guardianship or protection of vulnerable adult.\n* Patients with implantable electro-medical devices.\n* Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.\n* Infected wounds requiring urgent medical or surgical treatment before the application of any device.",{"count":415,"type":22},66,[25],"The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone?\n\nResearchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing.\n\nParticipants will:\n\n* Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization.\n* Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires.\n* Be followed up at home by nurses for wound care, treatment administration and clinical assessment too.\n* Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.",[419,28,177,178],"Chronic Wounds",[421,31,126,206,208,422,423,424,425,426,427,428,429],"Chronic wounds","Pressure Ulcer","PU","Cold Atmospheric Plasma","CAP","Plasma","Cold Plasma","Healing","Wound Closure","2025-04-30",{"date":432,"type":44},"2025-05-09",{"date":434,"type":22},"2025-06",{"date":70,"type":22},{"name":437,"class":75},"Plasana Medical",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":174,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":52},"100569721","evaluating-the-durability-of-closure-for-venous-leg-ulcers-100569721","NCT06697925","Evaluating the Durability of Closure for Venous Leg Ulcers","Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial","THORSDOTTIR","Inclusion Criteria:\n\n* 1\\. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.\n\nExclusion Criteria:\n\n* 1\\. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.",{"count":261,"type":22},"The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.",[449,28,31,210,126],"Venous Leg","2025-01-22",{"date":452,"type":44},"2025-01-24",{"date":454,"type":22},"2025-01",{"date":190,"type":22},{"name":457,"class":75},"Kerecis Ltd.",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":52},"100569386","phase-4-evaluating-intact-fish-skin-graft-and-standard-of-care-versus-standard-of-care-alone-in-nonhealing-venous-leg-ulcers-100569386","NCT06693570","Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers","A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers","THOR","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.\n3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n4. At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.\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, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer.\n7. Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.\n8. Subjects must consent to using the prescribed compression method for the duration of the study.\n9. Subjects must agree to attend the weekly study visits required by the protocol.\n10. Subjects 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 index ulcer is determined to be due to a condition other than venous insufficiency.\n3. The target ulcer exposes muscle, tendon, or bone.\n4. The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.\n5. The target ulcer has known or suspected skin malignancy.\n6. The target ulcer has been previously exposed to radiation.\n7. The target ulcer duration is greater than one year having received high level compression without closure for a year or more.\n8. The potential subject has end stage renal disease requiring dialysis.\n9. 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).\n10. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n11. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a cellular or tissue-based product (CTP) in the 30 days prior to the initial screening visit.\n12. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n13. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n14. 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). Digital planimetry is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n15. 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.\n16. The potential subject has a Functional Ambulatory Category Score (FACS) of less than 3.\n17. The potential subject has a body mass index (BMI) greater than 42\n18. In the last 8 weeks the patient has undergone revascularization (surgical or stenting) to the affected leg.\n19. Venous intervention in the affected limb in the last 30 days.\n20. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.\n21. Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling\u002Funable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).\n22. Know allergy to any of the components of fish skin or bovine collagen.\n23. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n24. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":261,"type":22},[203],"The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG\u002FSOC) versus standard of care alone (SOC) over 12 weeks.",[28,315,449,470],"Nonhealing Venous Leg Ulcer",[472,473],"Fish Skin Graft","Intact Fish Skin Graft",{"date":452,"type":44},{"date":476,"type":44},"2024-11-25",{"date":478,"type":22},"2026-11",{"name":457,"class":75}]