[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-leg-ulcers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-leg-ulcers":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,77,107,134,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100623364","subcutaneous-dexpanthenol-administration-and-wound-epithelialization-100623364",false,"NCT07395674","Subcutaneous Dexpanthenol Administration and Wound Epithelialization","Evaluation of the Effect of Subcutaneous Dexpanthenol Administration on Wound Epithelialization: A Pilot Randomized Controlled Study","DEXPAN-WOUND","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Presence of a chronic wound, including diabetic foot ulcer, venous leg ulcer, or arterial ulcer.\n* Target wound size between 1 and 20 cm² at baseline.\n* Non-infected wound, defined by the absence of purulent discharge, foul odor, spreading erythema, cellulitis, or systemic signs of infection.\n* Clinically stable patients without the need for systemic antibiotic therapy.\n* Ability to understand the study procedures and provide written informed consent.\n* Willingness and ability to comply with study visits and treatment schedule.\n\nExclusion Criteria:\n\n* Clinical signs of wound infection or requirement for systemic antibiotic treatment.\n* Critical limb ischemia, defined as ankle-brachial index \\\u003C0.5, rest pain, gangrene, or extensive tissue necrosis.\n* Wounds exposing bone, tendon, or joint structures, or suspected osteomyelitis.\n* Wound size smaller than 1 cm² or larger than 20 cm².\n* Malignant, autoimmune, vasculitic, or specific dermatologic conditions causing the wound.\n* Known hypersensitivity or allergy to dexpanthenol or any component of the study treatments.\n* Pregnancy or breastfeeding.\n* Cognitive impairment or inability to provide informed consent.\n* Participation in another interventional clinical trial that could interfere with the outcomes of this study.\n* Any medical condition that, in the investigator's judgment, could compromise participant safety or study integrity.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients.\n\nDexpanthenol is a vitamin B5 derivative that supports skin repair and tissue regeneration. It is widely used in topical treatments, and injectable forms are approved for clinical use. However, the effects of subcutaneous (under the skin) dexpanthenol injections on chronic wound healing have not been sufficiently studied in clinical settings.\n\nThe purpose of this study is to evaluate whether adding subcutaneous dexpanthenol injections to standard wound care improves wound healing compared with standard wound care alone. Adult patients with non-infected chronic wounds will be randomly assigned to one of two groups. One group will receive standard wound care only, while the other group will receive standard wound care plus subcutaneous dexpanthenol injections around the wound area.\n\nWound healing will be assessed by measuring changes in wound size and the degree of skin epithelialization over time using standardized and objective methods. Safety will be monitored by recording local reactions at the injection site and any other adverse events during the study.\n\nThe results of this study may provide preliminary clinical evidence on the effectiveness and safety of subcutaneous dexpanthenol as an additional treatment option for chronic wound management.",[27,28,29,30],"Chronic Wounds","Diabetic Foot Ulcer","Venous Leg Ulcers","Arterial Ulcer",[32,27,33,34,28,35,30,36],"Dexpanthenol","Wound Healing","Epithelialization","Venous Leg Ulcer","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-16",{"date":40,"type":41},"2026-04-21","ACTUAL",{"date":43,"type":21},"2026-08-02",{"date":45,"type":21},"2028-12-02",{"name":47,"class":48},"Dilara CANBAY OZDEMIR","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":49},"100632186","clinical-trial-evaluating-nushield-plus-standard-of-care-soc-versus-standard-of-care-soc-alone-in-the-management-of-non-healing-venous-leg-ulcers-vlus-100632186","NCT07510412","Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)","A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Index Ulcer must be of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and\u002For dermatitis) or other assessments (e.g. venous reflux test)\n3. The index ulcer must have been present for a minimum of 4 weeks\n4. The subject must have a study wound that falls within a specified size range\n5. If the 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 index ulcer.\n6. Index ulcer is located on the leg, below the knee and at or above the malleoli.\n7. Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.\n8. The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures.\n9. Subjects agree to be compliant with all study requirements, including weekly study visits.\n10. Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior to randomization and for the duration of study participation. Males must be willing to use acceptable methods of birth control (barriers or abstinence) from randomization through study participation.\n11. Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit:\n\n    1. TCOM \\> 30 mmHg\n    2. ABI \\> 0.75\n    3. SPP \\> 30mmHg\n    4. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.\n12. Subject failed to adequately respond to conventional therapy\n\nExclusion Criteria:\n\n1. Index ulcer is of non-venous pathophysiology.\n2. Subjects unable to tolerate sharp debridement and standard compression therapy.\n3. If, at the opinion of the investigator, the index wound requires debridement necessitating surgery or enzymatic therapies.\n4. The surface area measurement of the index ulcer has reduced in size by a specified amount from the initial screening visit (SV1) to Visit 1\u002Frandomization visit\n5. Subjects receiving systemic steroids greater than 5 mg of Cortisone per day or equivalent.\n6. A subject who, in the opinion of the Investigator, has a clinically relevant medical condition which could impact subject safety, impair treatment effectiveness, or otherwise interfere with their ability to comply with study requirements.\n7. Signs and symptoms of index ulcer infection, including but not limited to cellulitis or osteomyelitis (as evidenced by Investigator's exam or x-ray).\n8. Necrotic or avascular index ulcer beds.\n9. Index ulcer contains exposed muscle, tendon, bone, or joint capsule.\n10. Subjects receiving hemodialysis or having a creatinine level of \\> 3.0mg\u002FdL within 6 months of randomization.\n11. Subjects with an HbA1c level of \\>12% within 3 months of randomization (if the subject is diabetic).\n12. Topical application of steroids to the index ulcer surface within one month of initial screening.\n13. Subjects who are currently receiving, or who previously received at any time within one month prior to screening, immunosuppressive agents (including inhaled corticosteroids and oral cortisone 5 mg or more daily), radiation therapy, or chemotherapy. Anticipated use of any of the above agents is considered exclusionary.\n14. Subjects who are pregnant or breast-feeding.\n15. Subjects with a history of poor compliance with medical treatment or who are unwilling or unable to adhere to the protocol requirements.",{"count":58,"type":21},200,[24],"A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.",[29],[63,64,65,29],"VLU","Non- Healing Venous Leg Ulcers","Chronic Venous Leg Ulcers","RECRUITING","2026-04-01",{"date":69,"type":41},"2026-04-03",{"date":71,"type":21},"2026-03-18",{"date":73,"type":21},"2029-04",{"name":75,"class":76},"Organogenesis","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100627542","modified-platform-trial-assessing-multiple-umbilical-cord-based-camps-and-soc-v-soc-alone-in-the-treatment-of-hard-to-heal-vlus-100627542","NCT07449988","Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Umbilical CORD-Based Skin Substitutes and Standard of Care Versus Standard of Care Alone in the Treatment of Hard-to-Heal Venous Leg Ulcers","CORDSTIM-VLU","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.\n3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n5. The target ulcer must be full thickness on the foot or leg without exposed bone.\n6. 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 ≥ 30 mmHg;\n   4. PVR: biphasic.\n7. 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.\n8. Target ulcers must be treated with compression therapy for at least 14 days prior to enrollment.\n9. The potential subject must consent to using the prescribed compression therapy for the duration of the study.\n10. The potential subject must agree to attend the weekly study visits required by the protocol.\n11. 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 is infected or there is cellulitis in the surrounding skin.\n3. There is evidence of osteomyelitis or exposed bone, probes to the bone or joint capsule.\n4. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n6. The potential subject is taking hydroxyurea.\n7. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n8. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper treatment of the target ulcer.\n9. If the subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n10. The surface area of the target ulcer has reduced in size by more than 25% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period) or the 2 weeks from the initial screening visit (SV1) to the TV1\u002Frandomization visit during which time the subject received SOC. MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n11. Women who are pregnant or considering becoming pregnant within the next 6 months.\n12. The potential subject has end stage renal disease requiring dialysis.\n13. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n14. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n15. The target ulcer 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.\n16. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutrition Assessment.",{"count":86,"type":21},272,[24],"The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products\u002Fskin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.",[29,90,91,92,93],"Venous Leg Ulcers (VLUs)","Venous Leg","Leg Ulcers","Leg Ulcers Venous",[95,96,97],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Human Umbilical Cord (dHUC)","2026-02-26",{"date":100,"type":41},"2026-03-04",{"date":102,"type":21},"2026-07",{"date":104,"type":21},"2029-09",{"name":106,"class":76},"StimLabs",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":49},"100595340","educational-interventions-in-venous-leg-ulcer-100595340","NCT07031180","Educational Interventions in Venous Leg Ulcer","The Effect of an Educational Intervention in Patient's Knowledge and Self-care Skills in Adult Patients With Venous Leg Ulcer in Outpatient Clinic of \"Azienda ULSS 6 Euganea\": a Two-arm, Single Centre Randomized Controlled Trial","Inclusion Criteria:\n\n* older than 18 years;\n* with venous leg ulcer;\n* who understand Italian language;\n* who is able to read and understand the questions;\n* who attending to the nursing clinics involved in the study;\n* who have given consent to participate in the study;\n* who use a smart device with an internet connection or with caregiver able to provide the smart device as video player.\n\nExclusion Criteria:\n\n* with cognitive impairment;\n* who have an ankle-arm index\u002FWinsor's index (ABI) less than 0.90. \u002F with arterial insufficiency\n* patients with arterial or mixed-origin ulcers",{"count":115,"type":21},142,[24],"Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention.\n\nObjectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's\u002Fcaregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version.\n\nMethods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.",[29],[120,121,122,123,124],"venous leg ulcer","education","randomized controlled trial","knowledge","self-care skills","2025-06-29",{"date":127,"type":41},"2025-07-03",{"date":129,"type":21},"2025-09",{"date":131,"type":21},"2027-03",{"name":133,"class":48},"University of Padova",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":49},"100569386","phase-4-evaluating-intact-fish-skin-graft-and-standard-of-care-versus-standard-of-care-alone-in-nonhealing-venous-leg-ulcers-100569386","NCT06693570","Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers","A Randomized Controlled Multicenter Clinical Trial Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers","THOR","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.\n3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n4. At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, and they are separated by at least 2 cm post-debridement, the largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. If the potential subject has two or more ulcers and they are separated by less than 2cm, the entire wound area is designated as the target ulcer.\n7. Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.\n8. Subjects must consent to using the prescribed compression method for the duration of the study.\n9. Subjects must agree to attend the weekly study visits required by the protocol.\n10. Subjects must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The index ulcer is determined to be due to a condition other than venous insufficiency.\n3. The target ulcer exposes muscle, tendon, or bone.\n4. The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.\n5. The target ulcer has known or suspected skin malignancy.\n6. The target ulcer has been previously exposed to radiation.\n7. The target ulcer duration is greater than one year having received high level compression without closure for a year or more.\n8. The potential subject has end stage renal disease requiring dialysis.\n9. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n10. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n11. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a cellular or tissue-based product (CTP) in the 30 days prior to the initial screening visit.\n12. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n13. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n14. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Digital planimetry is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n15. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n16. The potential subject has a Functional Ambulatory Category Score (FACS) of less than 3.\n17. The potential subject has a body mass index (BMI) greater than 42\n18. In the last 8 weeks the patient has undergone revascularization (surgical or stenting) to the affected leg.\n19. Venous intervention in the affected limb in the last 30 days.\n20. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator.\n21. Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling\u002Funable to use acceptable methods of contraception (birth control pills, barriers, or abstinence).\n22. Know allergy to any of the components of fish skin or bovine collagen.\n23. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n24. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":143,"type":21},150,[145],"PHASE4","The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG\u002FSOC) versus standard of care alone (SOC) over 12 weeks.",[148,29,91,149],"Venous Leg Ulcer (VLU)","Nonhealing Venous Leg Ulcer",[151,152],"Fish Skin Graft","Intact Fish Skin Graft","2025-01-22",{"date":155,"type":41},"2025-01-24",{"date":157,"type":41},"2024-11-25",{"date":159,"type":21},"2026-11",{"name":161,"class":76},"Kerecis Ltd.",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":49},"100574874","clinical-trial-evaluating-an-amnion-membrane-allograft-intended-for-use-in-the-management-of-non--healing-venous-leg-ulcers-versus-standard-of-care-alone-100574874","NCT06764953","Clinical Trial Evaluating an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone","A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Venous Leg Ulcers Versus Standard Of Care Alone","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with manual measure.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. If the 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.\n5. The subject must consent to using the prescribed off-loading method for the duration of the study.\n6. The subject must agree to attend the weekly study visits required by the protocol.\n7. The subject must be willing and able to participate in the informed consent process.\n8. The target ulcer must be full thickness on the foot or leg that does not probe to bone.\n9. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:\n\n   1. TCOM ≥30 mmHg\n   2. ABI between 0.7 and 1.3\n   3. PVR: Biphasic\n   4. TBI ˃0.6\n   5. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle\n10. If the 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.\n11. Target ulcers must have been treated with compression therapy for at least 14 days prior to randomization.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\\u003C 6 months is excluded.\n2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.\n4. Index ulcer and\u002For index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled\n5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n7. A subject with a previous partial amputation on the affected leg is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n8. If a subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he\u002Fshe is excluded.\n9. If a subject has a serum creatinine ≥ 3.0mg\u002FdL within 6 months of randomization he\u002Fshe is excluded.\n10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1\u002Frandomization visit during which time the subject received SOC.\n11. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n12. A potential subject with end stage renal disease requiring dialysis is excluded.\n13. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n14. A subject treated with hyperbaric oxygen therapy or a Cellular and\u002For Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded",{"count":170,"type":21},100,[24],"The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following:\n\n* Rate of wound closure\n* Change in ulcer size over 12 weeks\n* Any adverse events or reactions (side effects)\n* Change in pain levels\n* Occurrence of infection",[29],"2025-01-07",{"date":176,"type":41},"2025-01-09",{"date":178,"type":41},"2024-12-28",{"date":180,"type":21},"2025-12",{"name":182,"class":76},"Skye Biologics Holdings, LLC"]