[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-leg-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-leg-ulcer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,42,66,105,145,170,198,233,266,291,314,335,360,390,419,444,472,494,520,545,567,589,609,632,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100618764","evaluation-of-the-efficacy-of-hyalomatrix-in-the-healing-of-chronic-venous-leg-ulcers-100618764",false,"NCT07335861","Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers","Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound\n3. Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has a venous leg ulcer without infection or clinically visible exposed bone\n7. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit\n8. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n9. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1\n10. Index wound is free of necrotic debris prior to Hyalomatrix application\n11. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n12. Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more wounds are present, the wounds must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity\n2. Subject has a known life expectancy of \\\u003C1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications to tissue-engineered allograft\n8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Venous leg ulcer with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index wound leg within 30 days of screening phase\n16. Index wound suspicious of neoplasm in the opinion of the principal investigator","ALL","18 Years",{"count":20,"type":21},122,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.",[27,28],"Venous Leg Ulcer","Chronic Wounds","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":33},"2026-05-14",{"date":37,"type":21},"2027-01-31",{"name":39,"class":40},"NuScience Medical Biologics, LLC","INDUSTRY",4,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100412183","phase-2-mtx-001-for-the-treatment-of-non-healing-venous-stasis-ulcers-100412183","NCT04647240","MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers","A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers","Inclusion Criteria:\n\n* Patients who voluntarily give written informed consent to participate in study\n* Males and female patients aged 18 to 75 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 1 only\n* Males and female patients aged 18 to 90 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 2 only\n* Patients having a full thickness ulcer that meets the following criteria:\n\n  * Ulcer surface area ≥ 4 cm2 and \\\u003C 25 cm2\n  * Ulcer surface area hasn't increased or decreased by 40% or more, as assessed within 28 days prior to Baseline\n  * Ulcer depth ≥ 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound.\n  * Ulcer age \\\u003C 36 months (1095 days) prior to Baseline (for Part 2 only)\n* Received ≥ 28 days of standard, conventional wound therapy with a therapeutic high-compression (≥40 mmHg), multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, patients may have received other wound treatments as needed (e.g., surgical debridement, pressure offloading, negative pressure and\u002For hyperbaric oxygen therapy).\n* Patient must have previously undergone venous hemodynamic correction via therapeutic compression (≥40 mmHg), surgical venous stripping, sclerotherapy, endovenous laser ablation, and\u002For endovenous radiofrequency ablation.\n* Patient must have adequate circulation to the affected extremity as demonstrated by the most recently measured ankle-brachial index (ABI) greater than or equal to 0.8 and less than or equal to 1.2 or triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg (as applicable). If patient has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, patients must have transcutaneous oximetry (TcPO2) \\> 40 mmHg.\n* Patient must have VSU caused by underlying venous reflux disease with physiological reflux lasting greater than or equal to 500 milliseconds for superficial veins OR 1.0 seconds for deep veins, as confirmed by most recent Doppler ultrasound venous mapping from Baseline; historical results\u002Fconfirmation within the previous three years allowed.\n* Patients who agree to follow the specified precautions to avoid pregnancy as follows:\n\n  * Patients who are female of childbearing potential include any female patient who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). For female patients of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating Study Product. Female patients of childbearing potential must follow 1 of the following approaches:\n  * Practice actual abstinence from intercourse\n  * Have a partner with a vasectomy\n  * Have an intrauterine device\n  * Must use 2 different forms of highly effective contraception for the duration of the study, and for at least 48 hours after discontinuing study drug. Medically acceptable forms of effective contraception include approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm).\n  * Male patients with a partner of childbearing potential must use a condom during intercourse for the duration of the study, and for 48 hours after discontinuing study drug.\n* Patients who, in the opinion of the Investigator, are capable of communicating effectively with study personnel and are considered reliable, willing, and likely to be cooperative with protocol requirements and attend all required study visits.\n* Patients who have the capability to answer surveys and questionnaires written in English.\n\nExclusion Criteria:\n\n* Patient must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment according to The International Wound Infection Institute (IWII) criteria (e.g. odor, color, visual appearance) rather than culture.\n* Ulcer must not have exposed bone, tendon, or ligament.\n* Patient must not have another ulcer within 2 cm from the ulcer receiving investigational treatment.\n* Female patients who are pregnant, lactating, or planning to become pregnant during the study.\n* Patients actively receiving or received any skin graft substitute within 30 days prior to Baseline.\n* Patients receiving oral, systemically administered, or lower extremity injectable corticosteroid therapy within 60 days prior to Baseline.\n* Patients with angiographic or clinical signs of peripheral arterial disease (PAD)\n* Patients with underlying osteomyelitis.\n* Patients with an active infection or condition that would interfere with interpretation of study assessments.\n* Patients with an HbA1c \\> 7.0% (Part 1 only) or HbA1c \\> 10.0% (Part 2 only), as collected at Screening or in the previous 90 days prior to Screening.\n* Patients with current deep vein thrombosis (DVT) (Part 2 only)\n* Patients with chronic musculoskeletal disorder or any other disease that would limit ambulation.\n* Patients with a history of alcohol abuse or illicit drug abuse within 6 months of Baseline which, in the Investigator's opinion, would make the patient inappropriate for enrollment in a clinical study.\n* Patients with any other concomitant disease with life expectancy of \\\u003C12 months from Baseline\n* Patients with an unstable psychiatric condition or those not capable of understanding the objectives, nature, or consequences of the study, or who have any condition which, in the Investigator's opinion, would constitute an unacceptable risk to the patient's safety.\n* Patients who are currently receiving an investigational drug, have an investigational device in place, or who have participated in an investigational drug or device study within 90 days prior to Baseline. Participation in an observational study within 90 days prior to Baseline does not disqualify a patient from enrolling.\n* Patients who have received another regenerative therapy within 30 days prior to Baseline.\n* Patients with a Body Mass Index (BMI) \\> 45 (Part 2 only) or other clinical symptoms (e.g. edema) that do not allow for adequate therapeutic compression.",{"count":50,"type":21},80,[52],"PHASE2","DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.",[55,27],"Venous Stasis Ulcer","2026-06-17",{"date":58,"type":33},"2026-06-22",{"date":60,"type":33},"2022-02-26",{"date":62,"type":21},"2027-05-31",{"name":64,"class":40},"Merakris Therapeutics",11,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100628571","phase-1-lut017-gel-for-venous-leg-ulcers-and-chronic-non-healing-skin-wounds-in-adults-100628571","NCT07463365","LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults","A Phase 1, Open-Label Clinical Trial to Assess the Safety, Tolerability, and Preliminary Efficacy Study of Topically Administered LUT017 Gel for Cutaneous Wound Healing","Inclusion Criteria\n\n1. Subjects with venous leg ulcers (VLU), defined by open skin lesion of the leg as a result of venous hypertension.\n2. Subject must be ≥ 18 years of age.\n3. Active lower extremity ulceration (CEAP classification of C6).\n4. Non-healing VLU ≥ 4 weeks but not greater than 24 months.\n5. Ulcer size ≥ 2cm2 ≤ 20cm2.\n\n   a. Target ulcer will be defined as the largest ulcer on the affected limb. Only one wound per subject will be designated as the study wound and treated with the investigational gel. If a subject has two wounds separated by less than 1 cm of intact skin, these wounds will be considered a single study wound, and the surface areas of both wounds will be added together for eligibility purposes; if the combined area exceeds 20 cm², the subject will be excluded from the study. Although only one wound will be directly treated, local activation of the MAPK pathway may result in biological stimulation of the adjacent untreated wound when wounds are separated by less than 1 cm.\n6. Chronic venous insufficiency confirmed by ultrasound within previous 12 months.\n7. Adequate perfusion confirmed within the past 12 months.:\n\n   1. Dorsalis Pedis (DP) or Posterior Tibial (PT) systolic pressure ≥ 60mmHg on the study limb.\n   2. Transcutaneous partial pressure oxygen (TcP02) \\> 30mmHg.\n   3. Great toe systolic pressure \\> 40mmHg.\n8. Must be able and willing to provide informed consent prior to study participation.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0). They should agree to use highly effective methods of birth control, defined as those with failure less than 1%, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUD's), sexual abstinence, or a vasectomized partner. Such subjects should agree to have monthly pregnancy test documented.\n\nExclusion Criteria\n\n1. Target ulcer has exposed of tendon, muscle, or bone.\n2. Target ulcer is of non-venous etiology.\n3. Target ulcer has been treated with living cellular therapy within 4 weeks of the randomization.\n4. Target ulcer shows any signs of infection (only non-infected ulcers are eligible).\n5. Patient has undergone endovenous ablation or other venous surgery within 4 weeks of enrollment.\n6. Unable to tolerate multi-layer bandages or compression garments.\n7. Decompensated congestive heart failure within 4 weeks of screening.\n8. Active soft tissue or bone infection requiring antibiotics.\n9. Skin cancer on the target limb within the last 24 months.\n10. Actively receiving chemotherapy and\u002For radiation therapy for cancer.\n11. Treatment with a serine\u002Fthreonine-protein kinase BRAF inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib) or Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer.\n12. Blood chemistry or counts values as follows:\n\n    1. White Blood Cells (WBC)\\\u003C 1.5 x 109\u002FL.\n    2. Absolute \\\u003C 0.9 x 109\u002FL.\n    3. Platelet count \\\u003C 50 x 109\u002FL.\n    4. Alanine aminotransferase \\> 3 x upper limit of normal.\n    5. Aspartate aminotransferase \\> 3 x upper limit of normal.\n    6. Serum albumin \\\u003C2.0 g\u002FdL.\n    7. HbA1c value of \\> 12% within the past three (3) months.\n13. Current use of systemic corticosteroids \\> 5 mg daily or equivalent within 4 weeks.\n14. Currently pregnant or trying to become pregnant.\n15. Inability or unwillingness to participate in all aspects of study protocol or as determined by the Investigator.\n16. Known hypersensitivity to the ingredients of the study drug.",{"count":74,"type":21},18,[76],"PHASE1","This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with conditions like diabetes or obesity.\n\nLUT017 is a gel that will be applied directly to the surface of these wounds. The goal of the study is to find out if the gel is safe and well tolerated when applied once a week for up to 8 weeks. The researchers will also look for early signs of whether the gel helps the wounds heal more quickly or completely. The gel contains a medicine that has been shown in animal studies to activate natural skin repair processes and promote cell growth, potentially speeding up the healing process.\n\nThe study will involve between 12 and 18 adult participants who have had a chronic leg wound for at least 4 weeks. All participants will go through a screening process to make sure they are eligible. If they qualify, they will first complete a two-week \"run-in\" phase where their wound will be treated with standard medical bandages. This phase helps ensure that only participants whose wounds are not healing with normal care are included.\n\nIf participants remain eligible after this period, they will start the treatment phase. During this phase, they will come to the clinic once a week for 8 weeks to receive the LUT017 gel treatment directly on their wound. Each visit will include a physical exam, vital signs, wound evaluation, photographs of the wound, and blood tests to monitor safety.\n\nAfter the 8-week treatment period, participants will return for two follow-up visits-one at 3 months and one at 6 months after their first treatment. These visits will help the researchers understand how long any benefits of the treatment might last and monitor for any delayed side effects.\n\nIn total, participants will be involved in the study for about 6.5 months and will have approximately 12 to 14 visits to the clinic. Participation is entirely voluntary, and individuals can withdraw at any time. The research team is committed to ensuring participant safety and privacy throughout the study.",[27,79,80],"Chronic Non-Healing Cutaneous Wounds","VLU",[27,82,83,84,85,86,87,88,89,90,91,92],"Chronic Wound Healing","Topical BRAF Inhibitor","LUT017","Paradoxical MAPK Activation","Epidermal Regeneration","Cutaneous Wound Healing","Phase 1 Clinical Trial","Dose Escalation Study","Re-epithelialization","Dermatologic Regenerative Therapy","Local MAPK Activation","NOT_YET_RECRUITING","2026-05-26",{"date":96,"type":33},"2026-05-29",{"date":98,"type":21},"2026-10-02",{"date":100,"type":21},"2027-06",{"name":102,"class":103},"Antoni Ribas","OTHER",1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":123,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355","NCT07538609","The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study","Preoperative Inclusion Criteria:\n\n* Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator\u002Fsub-investigator.\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent themself.\n\nIntraoperative Inclusion Criteria:\n\n* Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow\u002Foutflow to\u002Ffrom the target lesion(s), per investigator\u002Fsub- investigator discretion.\n* Lesion can be traversed with a guidewire.\n\nIntraoperative Exclusion Criteria:\n\n* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.",{"count":112,"type":21},150,[24],"This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[116,117,27,118,119,120,121,122],"Venous Thromboses","Venous Disease","Venous Stasis","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[124,125,126,120,127,128,129,130,131,132,117,133,134,135,136],"Vein Stent","VIAFORT","Venous Thrombosis","Gore","Venous occlusion","VIABAHN FORTEGRA","FORTEGRA","Deep Venous Insufficiency","Deep venous","DVT Treatment","Venous Stent","Venous insufficiency treatment options","Venous disease treatment options","2026-05-11",{"date":35,"type":33},{"date":140,"type":21},"2026-10-07",{"date":142,"type":21},"2031-05",{"name":144,"class":40},"W.L.Gore & Associates",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},"100597678","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-venous-leg-ulcers-100597678","NCT07061613","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers","Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound\n3. Subject has an venous leg ulcer without infection or clinically visible exposed bone\n4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit\n5. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1\n7. Index wound is free of necrotic debris prior to NeoThelium FT application\n8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit\n9. Wound free of clinical signs\u002Fsymptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.\n10. Subject is able and willing to follow the protocol requirements\n11. Subject had signed informed consent\n12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject is unable to comply with protocol treatment\n2. Presence of infection prior to screening.\n3. Multiple VLUs on the same leg with \\\u003C 2 cm separation from the target ulcer.\n4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.\n8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment\n12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":153,"type":21},10,[24],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers",[27],[28,158,159,160],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","2026-05-05",{"date":163,"type":33},"2026-05-06",{"date":165,"type":33},"2025-09-02",{"date":167,"type":21},"2026-07-29",{"name":39,"class":40},2,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":153},"100556727","phase-4-coms-for-chronic-ulcers-treatment-100556727","NCT06528873","COMS for Chronic Ulcers Treatment","NAZARÉ: Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Patients With Chronic Ulcers of Vascular Origin in a Real-world Setting Including Care at Patient's Home, a Prospective Randomized, Controlled, Assessor Blinded, Phase IV, Clinical Trial","NAZARÉ","Inclusion Criteria:\n\nAge ≥ 18 years Clinical diagnosis of venous leg ulcer (VLU) or VLU with peripheral arterial disease (PAD) Ankle-brachial index (ABI) 0.5-1.3 or ankle pressure \\> 60 mmHg Ulcer size 2-50 cm² after debridement at screening Ulcer duration \\> 30 days and \\\u003C 2 years For patients with diabetes: HbA1c ≤ 12% at screening Able and willing to provide written informed consent prior to study procedures\n\nExclusion Criteria:\n\nPregnant or breastfeeding Malignancy in the ulcer area Use of photosensitizing medication within 30 days Severe immunosuppression (including chronic corticosteroid use \\> 10 mg\u002Fday prednisolone equivalent) NYHA class III or IV heart failure End-stage renal disease requiring dialysis Ulcer area reduction \\> 30% during run-in phase Active infection requiring systemic antibiotics at baseline Use of advanced wound therapies (e.g., negative pressure wound therapy, skin substitutes, hyperbaric oxygen) within 2 weeks prior to screening Participation in another interventional clinical trial within 30 days",{"count":20,"type":21},[180],"PHASE4","Chronic leg and foot ulcers are defined as wounds that fail to heal in a timely manner, typically persisting for over 4 to 8 weeks without substantial healing despite standard care. These ulcers often result from macro- and microvascular disorders, the most common being chronic venous insufficiency (CVI), alone or with peripheral artery disease (PAD) or microangiopathy. Despite different causes, chronic vascular-origin wounds share similar biological traits and require the same physiological processes for healing.\n\nVascular issues hinder blood perfusion, reducing oxygen, nutrients, and growth factors, leading to decreased energy metabolism and impaired cell functions necessary for proliferation, extracellular matrix production, angiogenesis, and tissue regeneration. Reduced blood supply also limits leukocyte function, compromising the immune response and leading to persistent inflammation and infection. Consequently, these wounds cannot effectively heal, showing prolonged inflammation, persistent infections, and cellular senescence.\n\nBest practice wound care includes compression therapy and physical activity for venous ulcers, and angioplasty, surgery, or bypass for arterial ulcers. These treatments aim to improve blood flow, reduce venous stasis, and enhance venous return. Compression therapy and physical activity lower hydrostatic pressure in the lower limb, while angioplasty and surgery remove arterial blockages or create new blood flow routes.\n\nRecent studies highlight the role of mechano-sensitive (MS) ion channels in skin cell processes and their dysfunction in dermatological disorders. Magnetic stimulation can activate MS TRCP1 channels, enhancing mitochondrial respiration and mitochondriogenesis via the Ca2+\u002FCalModulin(CaM)\u002FNFAT\u002FPGC-1α pathway. Ca2+-activated calmodulin also catalyzes nitric oxide (NO), promoting vasodilation and tissue perfusion.\n\nBimodal red and near-infrared photobiomodulation can further increase mitochondrial respiration and ATP production by activating Cytochrome C oxidase and mitigating NO-induced downregulation. This synergistic mechanism of concurrent optical and magnetic stimulation (COMS) may amplify Ca2+ and NO-mediated processes like cell proliferation, migration, vasodilation, and angiogenesis while resolving inflammation. Thus, COMS may offer a promising therapy for chronic, inflammation-prone wounds.\n\nThe effectiveness of COMS has yet to be validated in large-scale studies. This proposal aims to assess the impact of COMS therapy combined with standard care versus standard care alone on healing, wound closure, recurrence, pain, quality of life, economic outcomes, and device usability in patients with venous leg ulcers (VLU) and VLU associated with PAD in a large-scale multicentric randomized controlled trial.",[27,183,184],"Wound Heal","Magnetic Field Exposure",[186,187,188],"Venous leg ulcer","optical stimulation","magnetic stimulation","2026-05-04",{"date":191,"type":33},"2026-05-08",{"date":193,"type":33},"2025-10-01",{"date":195,"type":21},"2026-09-30",{"name":197,"class":103},"Sebastian Probst",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":217,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":104},"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":207,"type":21},96,[24],"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.",[117,211,212,213,27,214,215,216],"Venous Insufficiency (Chronic)(Peripheral)","Venous Insufficiency of Leg","Venous Leg Ulcer (VLU)","Venous Hypertension Ulcers","Varicose Ulcers","Varicose Ulcer of Lower Limb",[218,219,220,221,222,223],"venous ulcers","varicose ulcers","photobiomodulation","lasers","phototherapy","venous leg ulcer","2026-04-27",{"date":226,"type":33},"2026-04-29",{"date":228,"type":21},"2026-05",{"date":230,"type":21},"2027-07",{"name":232,"class":103},"University of Nove de Julho",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":250,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":104},"100634554","paw-hydrogel-for-chronic-wound-healing-100634554","NCT07541196","PAW-Hydrogel for Chronic Wound Healing","Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration \\> 3 months.\n* Wound surface area between 2 cm² and 20 cm².\n* For diabetic patients: HbA1c \\\u003C 9% (stable metabolic control).\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Clinical or radiological evidence of osteomyelitis (Wagner grade \\> 3).\n* Severe arterial insufficiency (ankle-brachial index \\\u003C 0.5).\n* Use of systemic corticosteroids or immunosuppressants.\n* Pregnancy or lactation.\n* Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).\n* Active malignancy or undergoing chemotherapy\u002Fradiotherapy.\n* Participation in another interventional clinical trial within 30 days prior to screening.",{"count":241,"type":21},50,[24],"The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are:\n\n* Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care?\n* Does PAW-hydrogel reduce bacterial load in the wound bed?\n* Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)?\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week.\n* Control group: Standard advanced wound care (cleaning, debridement, conventional dressings).\n\nWound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.",[245,246,247,27,248,249],"Diabetic Foot Ulcer (DFU)","Pressure Ulcer (PU)","Wound Dehiscence","Arterial Ulcer","Chronic Wound",[251,252,253,28,254,255,256],"Plasma-Activated Water","PAW","Hydrogel","Diabetic Foot","Wound Healing","RONS","2026-04-14",{"date":259,"type":33},"2026-04-21",{"date":261,"type":21},"2026-04-20",{"date":263,"type":21},"2027-07-30",{"name":265,"class":103},"Benjamín Gonzalo Rodríguez Méndez",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100476872","the-gore-viabahn-fortegra-venous-stent-iliofemoral-study-100476872","NCT05489588","The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study","Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction","Preoperative Inclusion Criteria:\n\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent.\n* One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.\n* Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.\n* Estimated life expectancy ≥1 year.\n* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.\n\nPreoperative Exclusion Criteria:\n\n* Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.\n* Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.\n* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.\n* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):\n\n  1. uncorrected INR\\>2 (not as a result of warfarin or DOAC therapy), OR\n  2. platelet count \\\u003C50,000 or \\>1,000,000 cells\u002Fmm3, OR\n  3. white blood cell count \\\u003C3,000 or \\>12,500 cells\u002Fmm3\n* Patient has impaired renal function (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or is currently on dialysis.\n* Patient has uncorrected hemoglobin of \\\u003C9 g\u002FdL.\n* Patient has known history of antiphospholipid syndrome (APS).\n* Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.\n* Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index procedure.\n* Patient has had or requires open deep venous surgery in the target limb.\n* Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator\u002Fsub-investigator. Observational studies are permitted.\n* Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.\n* Patient has known sensitivity to device materials.\n* Patient has had prior stenting or grafts in the target vessels.\n* Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that can be managed, and with an active clinical plan in place may be eligible.\n* Patient has known history of intravenous drug abuse within one year of treatment.\n* Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).\n* Patient has a BMI \\>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.\n* Patient is actively undergoing or plans to begin cancer treatment.\n* Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.\n* Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).\n\nIntraoperative Inclusion Criteria:\n\n* Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and\u002For common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.\n* Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Lesion can be traversed with a guidewire.\n* Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.\n* Patient does not have significant (i.e., \\>20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.",{"count":274,"type":21},165,[24],"This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.",[116,117,27,118,119,120,121,122,278,279],"Vein Occlusion","Vein Disease",[125,124,126,120,127,121,130,129,117,131,281,132,133,134,135],"Venous disease treatment Options","2026-04-07",{"date":284,"type":33},"2026-04-09",{"date":286,"type":33},"2023-03-02",{"date":288,"type":21},"2031-03",{"name":144,"class":40},27,{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":4},"100587621","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-venous-leg-ulcers-100587621","NCT06930768","Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Venous Leg Ulcers: A Randomized Controlled Multicenter Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Venous Insufficiency with an open wound to the lower extremity\n3. Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization\n5. Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone\n7. Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit\n8. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization\n10. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n11. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Venous Leg Ulcer with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":299,"type":21},132,[24],"This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.",[27],[304,305,158,159,160],"Chronic wounds","Wound Medicine","2026-04-06",{"date":308,"type":33},"2026-04-13",{"date":310,"type":21},"2026-07-01",{"date":312,"type":21},"2027-06-01",{"name":39,"class":40},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":169},"100555669","study-assessing-complete-wound-healing-by-comparing-surgenex-pellograft-in-treating-dfu-and-sanograft-in-treating-vlu-to-soc-100555669","NCT06515093","Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC","A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating Diabetic Foot Ulcers (DFU) and SanoGraft® in Treating Venous Leg Ulcers (VLU) to SOC Treatment","Inclusion Criteria:\n\n1. Subject is at least 18 years of age\n2. Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes\n3. Subject's wound is located on foot or ankle (DFU) or leg (VLU)\n4. Subject has diabetic foot ulcer \\> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \\> 1.0 cm2 and ≤ 50 cm2\n5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg\n6. Subject is willing and able to comply with all protocol requirements\n7. Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)\n\nExclusion Criteria:\n\n1. Subject is pregnant\n2. Subject with diagnosed diabetes has HbA1C \\> 12 within 3 months Prior to randomization\n3. Subject has \\> 30% reduction in wound size after 2-week run-in period\n4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria\n5. Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI\n6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \\\u003C 10 mg per day of prednisone\n7. Subject is currently undergoing cancer treatment\n8. Subject has used biologic skin substitutes within 14 days of enrollment\n9. Subject has an allergy to suture material\n10. Subject has life expectancy less than six-months as assessed by the investigator\n11. Subject is participating in another clinical research study prior to this study completion",{"count":322,"type":21},180,[24],"The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.",[326,27],"Diabetic Foot Ulcer","2026-04-01",{"date":282,"type":33},{"date":330,"type":33},"2024-06-23",{"date":332,"type":21},"2027-09-08",{"name":334,"class":40},"Surgenex",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100609183","suprasorbxphmb-pro-vs-suprasorbxphmb-in-treatment-of-infected-venous-leg-ulcers-100609183","NCT07211243","Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers","Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Infected\\* venous\\*\\* leg ulcer\n* Slightly to moderately exuding wound\\*\\*\\*\n* Patient has signed informed consent\n\n  * as per CDC definition, also TILI score ≥ 5 \\*\\* ABPI \\> 0.8 and \\\u003C 1.2 \\*\\*\\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases\n\nExclusion Criteria:\n\n* Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study\n* Wounds with exposed cartilage tissue (hyaline cartilage)\n* Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)\n* Known allergy and\u002For hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and \u002F or interpreta-tion of the study results.",{"count":112,"type":21},[24],"This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.",[27],[347,348,349,350],"maceration","bacterial cellulose dressing","PHMB","antimicrobial dressing","2026-03-26",{"date":327,"type":33},{"date":354,"type":33},"2025-09-23",{"date":356,"type":21},"2027-06-15",{"name":358,"class":40},"Lohmann & Rauscher",9,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100570426","phase-3-tissue-repair-gel-in-venous-leg-ulcers-us-100570426","NCT06707090","Tissue Repair Gel in Venous Leg Ulcers (US)","A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)","TRIVIA","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* Participants considered nutritionally deficient.",{"count":369,"type":21},312,[371],"PHASE3","The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.",[27,119,55,118,183,374,212,375],"Wounds","Non-healing Wound",[377,378,379,380,80],"Tissue Repair","Glucoprime","TR Therapeutics","Debridement","2026-02-09",{"date":383,"type":33},"2026-02-12",{"date":385,"type":33},"2025-01-28",{"date":387,"type":21},"2028-02",{"name":379,"class":40},33,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":406,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":104},"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":241,"type":21},[180],"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.",[326,401,402,403,213,27,119,404,405],"Foot Ulcer Chronic","DFU","Ulcer Foot","Leg Ulcers","Ulcer",[407,405,119,408,80,402,326,409,410],"Leg Ulcer","Venous Leg ulcer","Foot Ulcer","Diabetic foot","2026-02-05",{"date":381,"type":33},{"date":414,"type":33},"2026-01-02",{"date":416,"type":21},"2027-01",{"name":418,"class":40},"BioLab Holdings",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":443},"100578485","non-healing-venous-leg-ulcers-treated-with-standard-care-with-or-without-br-ac-100578485","NCT06811909","Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC","A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC","Inclusion Criteria:\n\n1. Patient has signed the informed consent form.\n2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.\n3. Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.\n\n   1. If the subject presents with \\> 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.\n   2. If the target ulcer is \\\u003C 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.\n4. Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.\n5. Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).\n6. Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.\n\n   a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.\n7. Arterial supply adequacy confirmed by any one of the following:\n\n   1. Great toe pressure ≥ 50 mm\u002FHg\n   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10\n   3. TcPO2 ≥ 40 mmHg from the foot\n8. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.\n\nExclusion Criteria:\n\n1. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).\n2. 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.\n3. Clinical evidence of ulcer bed infection, or infected hardware.\n4. Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.\n5. Refusal or inability to tolerate compression therapy.\n6. Pregnant women.\n7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.\n8. Hemoglobin A1c (HbA1c) level is \\> 12% (108 mmol\u002Fmol).\n9. Current therapy with systemic antibiotics.\n10. Current therapy with cytotoxic agents.\n11. Current therapy with chronic (\\> 10 days) oral corticosteroids.\n12. Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).\n13. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).\n14. Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.\n15. Currently on dialysis or planning to start dialysis.\n16. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.\n17. Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.\n18. Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.\n19. Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.",{"count":427,"type":21},60,[24],"This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.\n\nThis study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.",[431,27,432,118,433],"Non-infected Venous Leg Ulcer","Venous Insufficiency","Venous Reflux","2026-01-21",{"date":436,"type":33},"2026-01-23",{"date":438,"type":33},"2025-02-14",{"date":440,"type":21},"2026-10",{"name":442,"class":40},"BioStem Technologies",23,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":104},"100612619","pmcf-study-of-debridement-pad-100612619","NCT07255937","PMCF Study of Debridement Pad","Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds","Inclusion Criteria:\n\n* Males or females aged 18 years or above.\n* Patients who can understand and give informed consent to take part in the study.\n* Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds\n* Wounds that require debridement due to the presence of slough debris\u002Ffibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin.\n* Wounds with both serous crusts and healthy tissue.\n* Minimum of 30% of the wound covered by debris, necrosis or slough.\n* Wound Size \\> 4cm2\n\nExclusion Criteria:\n\n* Patients who are known to be non-compliant with medical treatment\n* Patients who are known to be sensitive to any of the device components such as polyester.\n* Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study.\n* Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.\n* Symptoms \\& signs of systemic and \u002F or spreading wound infection (including erythema and fever).\n* Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area).\n* Subjects who in the view of the investigator might not be suitable for inclusion in the study",{"count":452,"type":21},184,[24],"The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.",[456,27,457,458,459,460,461,462],"Diabetic Ulcers","Arterial Leg Ulcer","Pressure Ulcer","Postoperative Wound Healing","Traumatic Wounds","Surgical Wounds","Burns and Scalds","2025-11-27",{"date":465,"type":33},"2025-12-01",{"date":467,"type":33},"2025-11-20",{"date":469,"type":21},"2026-07-10",{"name":471,"class":40},"Advanced Medical Solutions Ltd.",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":4},"100612272","cold-atmospheric-plasma-therapy-versus-standard-wound-care-in-diabetic-foot-and-venous-leg-ulcers-100612272","NCT07251426","Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS","Cold atmOspheric plaSMa Therapy Versus standArd Wound Care in Diabetic Foot and Venous Leg ulcerS - a Randomized Controlled Trial","COSMAS","Inclusion Criteria:\n\n* 1\\. is referred to one of the participating hospitals for treatment of a diabetic foot ulcer (DFU) or venous leg ulcer (VLU) with healing stagnation and\n\n  a. For VLU: i. An ulcer on the lower leg resulting from malfunctioning venous valves in the leg veins.\n\n  b. For DFU: i. An ulcer on the foot or lower leg in person with currently or previously diagnosed diabetes mellitus and usually accompanied by neuropathy and\u002For peripheral artery disease (PAD) in the lower extremity Note: In patients with both diabetes and chronic venous insufficiency, ulcers will be categorized as DFU in case of symptoms of diabetic neuropathy or loss of protective sensation, and otherwise categorized as VLU.\n\n  2\\. has a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 6 cm (\\~28 cm2 wound surface area for circular wounds; measured after debridement),\n\n  3\\. has a minimum age of 18 years old.\n\nExclusion Criteria:\n\n* 1\\. the participant has one or more of the following contraindications for PLASOMA:\n\n  1. extreme exudative wounds, i.e. wounds in which moisture is visible within seconds after patting dry;\n  2. any implanted active electronic device, such as a pacemaker, is present;\n  3. an electronic medical device attached to the body, for example electronic life support equipment, a hearing aid, insulin pump or dialysis machine. If this medical device can be disconnected, PLASOMA treatment may be performed. If the sole purpose of this medical device is monitoring, such as a glucose sensor, PLASOMA treatment is not contra-indicated but note that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment;\n  4. metal in the area 10 cm around pad-electrode area, e.g. metal sutures and implants;\n  5. connection from outside the body to (near) the heart is present, e.g. a central venous catheter;\n  6. the participant has epilepsy;\n  7. the participant is pregnant.\n\n     2\\. the participant has more than one wound that requires professional wound care.\n\n     3\\. for DFU the WIfI-classification is wound grade 3, defined as an extensive, deep ulcer involving forefoot and\u002For midfoot; deep, full thickness heel ulcer + calcaneal involvement.\n\n     4\\. presence of ischemia grade 2 or 3, according to the WIfI classification (= the ankle-brachial pressure index (ABI) is ≤0.59 OR the ankle systolic pressure is ≤69 mmHg OR the toe pressure is ≤39 mmHg; there should be at least one of these three measurements available).\n\n     5\\. a deep infection defined as an infection of the wound involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis).\n\n     6\\. the wound is located on a toe.\n\n     7\\. the participant receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if participant has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg\u002Fday prednisone or equivalent.\n\n     8\\. the participant is receiving or likely to receive offloading with a total contact cast or advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - for the to be-treated wound. Advanced wound dressings (including but not limited to hydrocolloid, hydrogel, alginate, collagen and antimicrobial dressings) are not excluded.\n\n     9\\. presence of a chronic or active skin disorder that may negatively influence wound healing (such as Marfan or Ehlers-Danlos syndrome).\n\n     10\\. the participant takes part in another study that is likely to compromise the outcome of this study or the feasibility of the participant fulfilling this study.\n\n     11\\. the participant is lactating.\n\n     12\\. the participant is unable to provide consent.",{"count":481,"type":21},494,[24],"Chronic wounds such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) pose a major health burden to the patients but also to the healthcare system because of their distorted healing capacity. This is mainly due to a prolonged treatment duration, high recurrence rates and substantial healthcare costs in wound care. Current guidelines exist that outline the standard wound care (SWC) in these patient groups but it often fails to achieve timely healing. Cold atmospheric plasma (CAP) is an emerging technology with promising antimicrobial and wound healing properties. In vitro and in vivo studies have highlighted the ability of CAP to reduce the bacterial biofilm load and stimulate tissue regeneration and microcirculation. This Randomized Controlled Trial (RCT) aims to evaluate the clinical effectiveness and cost-effectiveness of CAP in addition to SWC in patients with a DFU and VLU.",[326,27],"2025-11-24",{"date":487,"type":33},"2025-11-26",{"date":489,"type":21},"2025-11-30",{"date":491,"type":21},"2028-11-30",{"name":493,"class":103},"Olaf Bakker",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":519},"100596538","camp-rwe-trial-amnion-grafts-for-healing-hard-to-heal-ulcers-in-rw-populations-100596538","NCT07046767","CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMP RWE","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. 2\\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2\n4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n5. Subject is able and willing to follow the protocol requirements\n6. Subject has signed informed consent\n\nExclusion Criteria:\n\n1. Inability to adhere to the study protocol or study visit schedule\n2. Pregnancy\n3. Child-bearing potential without appropriate contraception\n4. Lactation\n5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.\n6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)\n7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety\n8. Known contraindications to the use of amniotic tissue grafts\n9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics",{"count":274,"type":21},[24],"CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[245,27,506],"Wound; Foot",[508,80,326,509],"DCF","Venus Leg Ulcer","2025-10-21",{"date":512,"type":33},"2025-10-22",{"date":193,"type":33},{"date":515,"type":21},"2026-07-20",{"name":517,"class":518},"Capsicure, LLC","NETWORK",7,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":527,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":104},"100340717","randomized-controlled-trial-for-treatment-of-pain-and-assessment-of-wound-healing-in-chronic-venous-leg-ulcers-using-near-infrared-laser-therapy-100340717","NCT03716167","Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy","Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers","Inclusion Criteria:\n\n* 18 yo or older\n* Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c\u002Fw stasis\n* Ulcer location in area of stasis present on lower limb\n* Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement\n* Ankle brachial index (ABI) \\> 0.8\n* Ulcer duration longer than 4 weeks\n* Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study\n\nExclusion Criteria:\n\n* Pregnant, nursing or child bearing potential\n* Venous ablation past 6 weeks and duration of study\n* Autoimmune disorder\n* Immune suppressive meds, Including steroids\n* Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c \\> 9)\n* Use of bioengineered products 30 days before and during the duration of study\n* 15\\\u003CBMI \\\u003C50\n* Use of oral or IV administered antibiotics within one week prior to randomization\n* Having tattoos in the region of skin above or adjacent to the ulcer where laser light might be applied.",true,{"count":529,"type":21},20,[24],"The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.",[27],[534,535,536],"laser","ulcer","wound","2025-08-26",{"date":539,"type":33},"2025-08-28",{"date":541,"type":33},"2018-07-27",{"date":440,"type":21},{"name":544,"class":103},"Wake Forest University Health Sciences",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":552,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":104},"100562672","innoven-efficacy-of-porcine-placental-extracellular-matrix-plus-standard-of-care-soc-versus-soc-alone-100562672","NCT06606210","INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone","An Observer-Blinded Multicenter Randomized Controlled Trial Evaluating Porcine Placental Extracellular Matrix as an Adjunct to Standard of Care Versus Standard of Care Alone in Hard-to-Heal Venous Leg Ulcers","Inclusion Criteria:\n\n1. Subjects must be at least 21 years of age or older.\n2. 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.\n3. The target ulcer must have been 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.\n4. No visible signs of improvement in the four weeks prior to randomization: less than 40% reduction in wound size over the 4 weeks prior to randomization.\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:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer exhibits signs or symptoms consistent with clinical infection, requiring topical antibiotic or antimicrobial agents or 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 Principal Investigator 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). 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).\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. The potential subject has had a lower extremity Deep Vein Thrombosis (DVT) to either limb within the previous 90 days.\n11. The potential subject is unable to tolerate therapeutic compression (30-40mmHg).\n12. Women who are pregnant or considering becoming pregnant within the next 6 months.\n13. The potential subject has end stage renal disease requiring dialysis.\n14. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days.\n15. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n16. 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.\n17. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n18. Potential subjects with a sensitivity or allergy to porcine materials or collagen.\n19. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials.\n20. A subject with a disorder that would create unacceptable risk of treatment complications.","21 Years",{"count":554,"type":21},120,[24],"INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers (VLUs).",[183,27],"2025-08-21",{"date":560,"type":33},"2025-08-22",{"date":562,"type":33},"2024-09-19",{"date":564,"type":21},"2026-04",{"name":566,"class":40},"ConvaTec Inc.",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":588,"locationsCount":104},"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":576,"type":21},650,[180],"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.",[254,402,326,580,403,27,407,581,405],"Foot Ulcer, Diabetic","Leg Ulcers Venous","2025-07-24",{"date":584,"type":33},"2025-07-28",{"date":586,"type":33},"2025-07-15",{"date":230,"type":21},{"name":418,"class":40},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":365,"acronym":366,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":372,"conditions":597,"keywords":599,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":608},"100570427","phase-3-tissue-repair-gel-in-venous-leg-ulcers-in-auus-100570427","NCT06707103","Tissue Repair Gel in Venous Leg Ulcers in AU\u002FUS","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* History of cancer in the preceding 5 years (except as noted in the protocol).\n* Participants considered nutritionally deficient.",{"count":369,"type":21},[371],[27,119,55,118,183,598,212,375],"Wound",[377,378,379,380,80],"2025-03-27",{"date":602,"type":33},"2025-04-02",{"date":604,"type":21},"2025-04",{"date":606,"type":21},"2027-02",{"name":379,"class":40},12,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":552,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":104},"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.",{"count":617,"type":21},340,[180],"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.",[27,621,254,326,580,403,407,622,405],"Venous Leg","Ulcer Venous","2025-02-12",{"date":625,"type":33},"2025-02-13",{"date":627,"type":33},"2024-12-06",{"date":629,"type":21},"2027-12",{"name":631,"class":40},"Tiger Biosciences, LLC.",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":653},"100539201","rct-exudate-management-cutimed-sorbion-product-range-100539201","NCT06300762","RCT Exudate Management Cutimed Sorbion Product Range","A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range","Inclusion Criteria:\n\n1. Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment\n2. Participant is mentally and physically able to participate in this study\n3. Men, women, diverse ≥ 18 years\n4. Participant complies with study visit schedule\n5. Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)\n6. Participant suffers from lower leg ulcer\\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:\n7. Ulcer is not younger than 4 weeks and not older than 1 year\n8. Ulcer is ranging between 2 cm2 and 800 cm2\n9. One side of the ulcer is not extending 40 cm\n10. Depth of ulcer \\\u003C 2 cm\n11. Ankle-brachial pressure index (ABPI) of \\>0.8 and ≤1.3, measurement not older than 12 months \\* Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.\n\nExclusion Criteria:\n\n1. Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)\n2. Participant is expected not to be willing or able to follow the study outlines and requirements\n3. Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS\n4. Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and\u002For systemic corticosteroids\n5. Participant uses any medication that could potentially delay the wound healing ability\n6. Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.\n7. Participant is pregnant or currently breastfeeding\n8. Participant reporting (and\u002For suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone\n\n8\\. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and\u002For joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis",{"count":640,"type":21},152,[24],"The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.\n\nAs primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.",[27],"2025-01-29",{"date":646,"type":33},"2025-01-31",{"date":648,"type":33},"2024-08-10",{"date":650,"type":21},"2025-12-31",{"name":652,"class":40},"BSN Medical GmbH",3,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":663,"phases":4,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":104},"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":112,"type":21},"OBSERVATIONAL","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.",[621,213,27,119,80],"2025-01-22",{"date":668,"type":33},"2025-01-24",{"date":670,"type":21},"2025-01",{"date":672,"type":21},"2026-12",{"name":674,"class":40},"Kerecis Ltd."]