[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-leg-ulcers-vlus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-leg-ulcers-vlus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,88,116,146],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"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",false,"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.","ALL","18 Years",{"count":20,"type":21},272,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31],"Venous Leg Ulcers","Venous Leg Ulcers (VLUs)","Venous Leg","Leg Ulcers","Leg Ulcers Venous",[33,34,35],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Human Umbilical Cord (dHUC)","NOT_YET_RECRUITING","2026-02-26",{"date":39,"type":40},"2026-03-04","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2029-09",{"name":46,"class":47},"StimLabs","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100588305","study-of-miro3d-wound-matrix-for-healing-wounds-and-ulcers-in-outpatient-care-100588305","NCT06939673","Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care","A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations","Inclusion Criteria:\n\n1. Age 18 or older and able to provide informed consent.\n2. Has an open wound or ulceration, preferably with tunneling or undermining.\n3. If multiple wounds\u002Fulcerations are present, only one will be selected for Miro3D treatment.\n4. Other wounds must be ≥2 cm away from the study wound.\n5. Wound should be debrided with a clinical goal of healing, even if some infection remains.\n6. Previous infections must be adequately treated and controlled (per IDSA guidelines).\n7. Willing and able to comply with offloading and\u002For compression requirements.\n8. Must have a stable living environment for wound care adherence.\n9. Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.\n10. Provides consent for digital photo documentation.\n\nExclusion Criteria:\n\n1. Active, untreated osteomyelitis.\n2. Malignancy or vasculitis at the wound site.\n3. Undergoing chemotherapy.\n4. On dialysis.\n5. Use of investigational drugs or therapies within 30 days before screening.\n6. Conditions that significantly impair study adherence or known history of medical non-compliance.\n7. Known sensitivity to porcine materials.\n8. Third-degree burns.\n9. Worsening ischemia or gangrene at screening.\n10. Prior radiation to the study wound site.\n11. Exposed hardware, implants, or fixation devices in the study wound.\n12. Receiving palliative or comfort care.",{"count":56,"type":21},20,[24],"This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort.\n\nThe study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat.\n\nParticipants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life.\n\nThe main goals of the study are:\n\n1. To measure how much the wound size shrinks (known as percent area reduction or PAR).\n2. To evaluate how much healthy granulation tissue (new tissue) forms in the wound.\n3. To compare healing outcomes when Miro3D is used weekly versus every two weeks.\n4. To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.\n\nEach participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.",[60,28,61,62,63,64],"Diabetic Foot Ulcers (DFUs)","Pressure Ulcers","Surgical Wound Dehiscence (SWD)","Chronic Wounds","Undermined and Tunneling Wounds",[66,67,68,69,70,71,72,73,74,75,76],"Miro3D Wound Matrix","Acellular Wound Matrix","Porcine-Derived Scaffold","Chronic Wound Healing","Diabetic Foot Ulcer Treatment","Pressure Ulcer Management","Surgical Wound Dehiscence Therapy","Venous Leg Ulcer Treatment","Tunneling and Undermining Wounds","Complex Wound Management","Reprise Biomedical","RECRUITING","2025-12-22",{"date":80,"type":40},"2025-12-24",{"date":82,"type":40},"2024-02-29",{"date":84,"type":21},"2025-12-31",{"name":86,"class":47},"Reprise Biomedical, Inc.",2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100610154","phase-3-efficacy-of-carbonlife-amniotic-tissue-product-in-the-treatment-of-chronic-wounds-100610154","NCT07223892","Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds","A Prospective Controlled Trial Evaluating the Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds: A Stratified Analysis by Wound Etiology and Care Setting","Inclusion Criteria:\n\n* Facilities and centers with the capacity to follow strict treatment and care guidelines for patients.\n* Adults aged 18 years or older.\n* Presence of a chronic wound (defined as a wound that has not shown significant improvement in 4 weeks) of any of the following etiologies: Diabetic foot ulcers, Venous leg ulcers, Arterial ulcers, Pressure ulcers, Burns, Trauma, Surgical\n* Wound size greater than 1 cm²\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Presence of active osteomyelitis\n* Untreated malignancy in the wound area\n* Known allergy to components of ATPs\n* Pregnant or breastfeeding women\n* Patients receiving immunosuppressive therapy\n* Patients with a life expectancy of less than 12 weeks",{"count":96,"type":21},600,[98],"PHASE3","Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs. These wounds are characterized by delayed healing and are often associated with complex etiologies and prolonged treatment courses. This study aims to evaluate the clinical efficacy and cost-effectiveness of Carbonlife amniotic tissue products (ATPs) compared to standard wound care in the management of chronic wounds. A prospective, controlled clinical trial will be conducted across diverse care settings and patient populations with varying wound etiologies. Participants will be stratified by wound type and treatment environment to enable subgroup analyses. The primary endpoint will assess wound healing outcomes, while secondary endpoints will include quality-of-life measures and healthcare resource utilization. The study is designed to generate high-quality evidence regarding the therapeutic value of ATPs in chronic wound management. Stratified analyses will provide insights into the differential effectiveness of ATPs across clinical contexts. Findings are anticipated to have implications for clinical practice guidelines and healthcare policy, with the goal of improving patient outcomes and optimizing resource allocation in wound care.",[63,28,60,101,61,102,103,104],"Arterial Ulcers","Burn Wounds","Trauma Wounds","Surgical Wounds",[106],"chronic wounds","2025-11-04",{"date":109,"type":40},"2025-11-06",{"date":111,"type":21},"2026-01-01",{"date":113,"type":21},"2028-03",{"name":115,"class":47},"Bardia Anvar",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100604684","assessing-connected-health-pressure-monitoring-technology-for-improving-compression-therapy-in-venous-leg-ulcer-treatment-100604684","NCT07152717","Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment","Assessment of a Connected-health, Pressure Monitoring Technology for Improving Clinical Outcomes of Compression Therapy in the Treatment of Venous Leg Ulcers","ACHIEVE","Inclusion Criteria:\n\n* Patient of Parkview Noble Center for Wound Healing\n* Adults 18+ with venous leg ulcers receiving compression therapy treatment prescribed by outpatient wound clinic.\n* Capable of using use a smart device\n* Owns a smart phone or device capable of downloading the Mobile App\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* Unable to consent in English\n* Cellulitis in affected limb\n* Acute deep vein thrombosis in affected limb\n* Active malignancy in affected limb\n* Prisoners\n* Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days",{"count":125,"type":21},40,[24],"This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs). Compression therapy is the standard of care for VLUs, but achieving and maintaining therapeutic sub-bandage pressure is challenging due to patient variability and lack of objective feedback. The Tight Alright system includes a wearable device that measures sub-bandage pressure at multiple points on the leg and transmits data to a mobile app and cloud database, enabling both guided compression application at the point-of-care and guided compression maintenance via remote monitoring.\n\nThe study will be conducted at Parkview Noble Center for Wound Healing and will include two cohorts: a control group receiving standard unguided compression therapy with blinded device use (i.e. compression pressures will be blinded at the point of care but monitored remotely), and an intervention group using Tight Alright technology to guide compression application and reapplication. Outcomes will include wound healing rates, time to healing, pressure maintenance, patient adherence, and usability. The study aims to determine whether integrating connected-health pressure monitoring can improve consistency of compression therapy, accelerate healing, and enhance patient engagement in the treatment of venous leg ulcers",[28],[130,131,132,133,134,135],"wound care","compression therapy","venous leg ulcers","remote monitoring","pressure sensing","connected health","2025-08-26",{"date":138,"type":40},"2025-09-03",{"date":140,"type":21},"2025-10-01",{"date":142,"type":21},"2026-12-31",{"name":144,"class":47},"Feeltect Limited",1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":154,"targetDuration":156,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":177,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":145},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":155,"type":21},300000,"5 Years","OBSERVATIONAL","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[160,161,162,163,164,165,166,167,168,169,28,170,171,172,60,173,101,174,175,176],"Diabetic Foot","Pressure Ulcer","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Leg Ulcer","Pyoderma","Peripheral Arterial Disease","Lymphedema","Surgical Complication","Calciphylaxis","Sickle Cell Ulcer","Pressure Ulcer (PU)","Pressure Injury","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[178,179,180,181,106,182,183,184,161,173,185,186,169,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic ulcers","Diabetic Foot Ulcer","Venous Leg Ulcer","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Advanced Wound Care","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Debridement","Standard of Care","2025-07-10",{"date":207,"type":40},"2025-07-16",{"date":209,"type":40},"2005-01-01",{"date":211,"type":21},"2030-01",{"name":213,"class":214},"U.S. Wound Registry","OTHER"]