[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-wounds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-wounds":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,79,105,135,161,185,213,248,275,310],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},122,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Venous Leg Ulcer","Chronic Wounds","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2026-05-14",{"date":36,"type":20},"2027-01-31",{"name":38,"class":39},"NuScience Medical Biologics, LLC","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100643797","miro3d-wound-matrix-for-treatment-of-diabetic-foot-ulcers-100643797","NCT07632001","Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers","A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers","FOCUS 3D","Inclusion Criteria\n\n1. Subjects 18 years of age or older.\n2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and\u002For insulin replacement therapy.\n3. A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.\n4. Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.\n5. Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.\n6. Index ulcer and\u002For index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.\n7. The subject is able and willing to follow the protocol requirements.\n8. Subject has signed informed consent.\n\n   Subjects with the following ulcer:\n\n   A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below the level of the malleolus. This includes DFUs as a result of open amputation sites and surgical wound dehiscence as long as all other criteria are met. \\[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 2 cm distant apart.\\]\n9. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; Toe pressures \\>50mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of \\>0.6 within 3 months of the first Screening Visit.\n10. Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.\n11. The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1\u002FRandomization).\n12. The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.\n\nExclusion Criteria\n\n1. Subject has a known life expectancy of \\\u003C 1 year.\n2. Index ulcer has been present for \\>1 year.\n3. Patient does not have adequate 2-week historical data demonstrating \\\u003C 25% area reduction.\n4. Subject is unable to comply with offloading device.\n5. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.\n6. Subject has ulcers that are completely necrotic or fibrotic tissue.\n7. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.\n8. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.\n9. The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.\n10. Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.\n11. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.\n12. Index ulcer has reduced in area by ≥25% after 2 weeks of standard of care from the first screening visit (S1) to the TV1\u002Frandomization visit.\n13. Subject is pregnant or breastfeeding.\n14. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.\n15. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) including any other CAMP within the last 30 days preceding the first treatment visit.\n16. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.\n17. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).\n18. Index ulcer and\u002For index limb with presence of gangrene or unstable ischemia at screening (SV1).\n19. Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).\n20. Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.\n21. Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.",{"count":50,"type":20},180,[23],"This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.\n\nDiabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone.\n\nMiro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone.\n\nApproximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits.\n\nThe primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.",[54,55,27],"Diabetic Foot Ulcers (DFUs)","Diabetic Foot",[57,58,59,60,61,62,63,64,65,66,67,68],"Miro3D","Wound Matrix","Extracellular Matrix","Acellular Dermal Matrix","Diabetic Foot Ulcer","Chronic Wound Healing","Advanced Wound Care","Randomized Controlled Trial","Wound Closure","Tissue Regeneration","Offloading","Debridement","2026-06-03",{"date":71,"type":32},"2026-06-08",{"date":73,"type":20},"2026-06",{"date":75,"type":20},"2027-05",{"name":77,"class":39},"Reprise Biomedical, Inc.",14,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100639478","theravex-tissue-care-spray-plus-for-the-management-of-cutaneous-wounds-burns-and-chronic-ulcers-100639478","NCT07617961","THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Inclusion Criteria\n\nAdult patients aged 18 years or older. Patients presenting with cutaneous wounds: burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions.\n\nPatients considered clinically suitable for topical treatment with THERAVEX Tissue Care Spray Plus.\n\nExclusion Criteria Known allergy or hypersensitivity to any component of THERAVEX Tissue Care Spray Plus.\n\nPresence of severe uncontrolled systemic infection requiring immediate surgical intervention.\n\nParticipation in another interventional clinical study that could interfere with wound healing assessment.",true,{"count":88,"type":20},26,"OBSERVATIONAL","Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.",[27,92,93,94,61],"Burns","Pressure Ulcer","Traumatic Wounds","2026-06-01",{"date":97,"type":32},"2026-06-04",{"date":99,"type":32},"2025-10-02",{"date":101,"type":20},"2027-05-21",{"name":103,"class":39},"Biointelligent Technology Systems SL",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":104},"100623364","subcutaneous-dexpanthenol-administration-and-wound-epithelialization-100623364","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.",{"count":114,"type":20},40,[23],"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.",[27,61,118,119],"Venous Leg Ulcers","Arterial Ulcer",[121,27,122,123,61,26,119,64],"Dexpanthenol","Wound Healing","Epithelialization","NOT_YET_RECRUITING","2026-04-16",{"date":127,"type":32},"2026-04-21",{"date":129,"type":20},"2026-08-02",{"date":131,"type":20},"2028-12-02",{"name":133,"class":134},"Dilara CANBAY OZDEMIR","OTHER",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":104},"100346617","genetic-and-epigenetic-basis-of-chronic-wounds-100346617","NCT03793062","Genetic and Epigenetic Basis of Chronic Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing to comply with protocol instructions, including all study visits and study activities.\n* Chronic wounds (\\> than four weeks since onset)\n* Clinically diagnosed diabetic or non-diabetic ulcer.\n* For patients with multiple wounds, the largest wound will be used for the study.\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks and benefits of the study,(i.e. unable to provide informed consent)\n* Pregnant females (self-declared) or lactating\n* Subjects with marked immunodeficiency (HIV\u002FAIDS or immune-suppressive medications)\n* Prisoners","100 Years",{"count":143,"type":20},256,"This pilot study is designed for chronic wounds that fail to heal in a timely manner carry specific genetic signatures. These genetic signatures will be studied using debrided wound tissue that is removed by the wound care provider as part of standard of care. The reference genomic signature will be evaluated by obtaining blood samples and will be compared with wound debrided tissue genomic signature to understand wound specific genomic changes.",[27],[147,148,149,150,151],"genome","epigenome","chronic wounds","genetics","socioeconomic","2026-04-08",{"date":154,"type":32},"2026-04-14",{"date":156,"type":32},"2018-12-04",{"date":158,"type":20},"2028-12-31",{"name":160,"class":134},"University of Pittsburgh",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100633612","impact-mdico-conomique-de-la-tlsurveillance-des-plaies-chroniques-avec-pixacare-100633612","NCT07528950","Impact médico-économique de la télésurveillance Des Plaies Chroniques Avec Pixacare","Medico-Economic Impact of Telemonitoring Chronic Wounds With Pixacare","IMETP","Inclusion Criteria:\n\n* Adult patient aged over 18 years\n* Suffering from a single chronic wound, meaning a wound of any origin evolving for more than 6 weeks (diabetic foot ulcer, leg ulcer, or pressure ulcer) Patient seen in a specialized consultation at Lille University Hospital (CHU de Lille) for wound management (Diabetology Department, Plastic Surgery Department)\n* A home-based wound-care protocol planned at the time of inclusion\n* Patients owning a smartphone or a tablet at home\n* Patient willing to comply with all study procedures and duration\n* Patient who has provided written informed consent to participate in the study\n* Patient covered by national health insurance\n\nExclusion Criteria:\n\n* Minor patient\n* Pregnant woman\n* Patient hospitalized at the time of inclusion (except for home hospitalization, HAD)\n* Multiple wounds\n* Wound not appearing flat in the photograph\n* A home nurse (RN) who is already following a patient from one study group may not follow another patient from the other group (control or telemonitoring) Inability to receive informed information, inability to participate in the full duration of the study, lack of health insurance coverage, refusal to sign the consent form\n* Patient under guardianship or curatorship",{"count":170,"type":20},100,[23],"The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.\n\nThe key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.\n\nThe Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.\n\nA review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.\n\nIt would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.\n\nAdverse developments and complications could also be detected and managed early through an alert system.\n\nNo controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.",[27],[175,176],"Home monitoring of chronic wounds","Pixacare","2026-04-07",{"date":154,"type":32},{"date":180,"type":20},"2026-04",{"date":182,"type":20},"2027-04",{"name":184,"class":134},"University Hospital, Lille",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100452483","diabetic-foot-ulcer-dfu-biofilm-infection-and-recurrence-100452483","NCT05172089","Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence","DFUBiofilm","Inclusion Criteria:\n\n* Male or Female, Age ≥ 18\n* Willing to comply with protocol instructions, including all study visits and study activities.\n* Patient with an open Diabetic Foot Ulcer\n* Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):\n* TcOM \\>30 mmHg\n* Ankle-brachial index at least ≥0.7\n* Toe pressure \\> 30 mmHg\n* TBI \\> 0.6 mmHg\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.\n* Wounds closed or to be surgically closed by flap or graft coverage\n* Subjects with marked immunodeficiency (HIV\u002FAIDS, or on immunosuppressive medications.\n* TcOM \\\u003C 30mmHg\n* Diabetics with a hemoglobin A1c \\> 15 within 3 months prior to enrollment\n* Subject with autoimmune connective tissue disease\n* Ulcer size and location that does not allow the TEWL measurement per SOP\n* Pregnant women\n* Prisoners\n* Unable to comply with study procedures and\u002For complete study visits",{"count":193,"type":20},405,"This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.",[27,196,197,55,198],"Biofilm Infection","Trans-epidermal Water Loss (TEWL)","Diabetic Foot Infection",[200,201,202,203],"foot ulcer","diabetic foot","wound infection","diabetic foot ulcer","2026-03-14",{"date":206,"type":32},"2026-03-18",{"date":208,"type":32},"2024-04-02",{"date":210,"type":20},"2029-06-27",{"name":160,"class":134},2,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":212},"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":221,"type":20},20,[23],"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.",[54,225,226,227,27,228],"Venous Leg Ulcers (VLUs)","Pressure Ulcers","Surgical Wound Dehiscence (SWD)","Undermined and Tunneling Wounds",[230,231,232,62,233,234,235,236,237,238,239],"Miro3D Wound Matrix","Acellular Wound Matrix","Porcine-Derived Scaffold","Diabetic Foot Ulcer Treatment","Pressure Ulcer Management","Surgical Wound Dehiscence Therapy","Venous Leg Ulcer Treatment","Tunneling and Undermining Wounds","Complex Wound Management","Reprise Biomedical","2025-12-22",{"date":242,"type":32},"2025-12-24",{"date":244,"type":32},"2024-02-29",{"date":246,"type":20},"2025-12-31",{"name":77,"class":39},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":259,"conditions":260,"keywords":265,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"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":256,"type":20},600,[258],"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.",[27,225,54,261,226,262,263,264],"Arterial Ulcers","Burn Wounds","Trauma Wounds","Surgical Wounds",[149],"2025-11-04",{"date":268,"type":32},"2025-11-06",{"date":270,"type":20},"2026-01-01",{"date":272,"type":20},"2028-03",{"name":274,"class":39},"Bardia Anvar",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100590179","evaluation-of-cold-plasma-in-chronic-wound-healing-100590179","NCT06964048","Evaluation of Cold Plasma in Chronic Wound Healing","Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.","PLASANAGENESIS","Inclusion Criteria:\n\n* Adult patient, age ≥ 18 years,\n* Patients affiliated with a social security system or benefiting from such a system,\n* Patients able and willing to provide written informed consent,\n* Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures,\n* Patients whose home healthcare professional is willing to follow the clinical investigation protocol,\n* Patient with gas conformed stockage area (ventilated or at least 7m²)\n* Patients without infection, or with a local controlled infection,\n* Patients with VLU:\n\n  * Patients with wound anteriority between 1 to 12 months\n  * Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8)\n  * Patients with VLU between 4 to 30 cm² in surface area,\n  * Patients with only one VLU,\n  * Patients who have not shown wound healing improvement after wearing compression system for at least two weeks\n* Patients with DFU:\n\n  * Patients with wound duration between 1 to 12 months\n  * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7\n  * Patients with DFU between 1 to 30 cm² in surface area,\n  * Patients with only one DFU, not between toes,\n  * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks,\n* Patient with PU:\n\n  * Patient with wound duration between 1 to 12 months\n  * Patient with PU stage 2 or 3 NPUAP grade,\n  * Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and\u002For Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot\n  * Patient with PU between 4 to 30 cm² in surface area,\n  * Patient with only one PU\n  * Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly,\n\nExclusion Criteria:\n\n* Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.\n* Patients with an active Charcot's neuro-arthropathy as determined by clinical and\u002For radiographic examination,\n* Patients with critical limb ischemia or severe PAD (ankle pressure \\\u003C 50 mmHg or Toe pressure \\\u003C 30 mmHg).\n* Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.\n* Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,\n* Patients with non-controlled systemic infection by a suitable antibiotic,\n* Patients with suspicion of severe malnutrition,\n* Pregnancy or breastfeeding woman, or susceptible to be pregnant,\n* Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,\n* Patients included in another study,\n* Patients under guardianship or protection of vulnerable adult.\n* Patients with implantable electro-medical devices.\n* Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.\n* Infected wounds requiring urgent medical or surgical treatment before the application of any device.",{"count":284,"type":20},66,[23],"The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone?\n\nResearchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing.\n\nParticipants will:\n\n* Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization.\n* Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires.\n* Be followed up at home by nurses for wound care, treatment administration and clinical assessment too.\n* Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.",[27,288,289,290],"Venous Leg Ulcer (VLU)","Diabetic Foot Ulcer (DFU)","Pressure Ulcer (PU)",[292,26,293,61,294,93,295,296,297,298,299,300,65],"Chronic wounds","VLU","DFU","PU","Cold Atmospheric Plasma","CAP","Plasma","Cold Plasma","Healing","2025-04-30",{"date":303,"type":32},"2025-05-09",{"date":305,"type":20},"2025-06",{"date":307,"type":20},"2026-05",{"name":309,"class":39},"Plasana Medical",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":86,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":104},"100548712","the-influence-of-systematic-psychological-intervention-on-patients-about-vsd-drainage-surgery-100548712","NCT06424561","The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery","The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds","Inclusion Criteria:\n\n\\- A mentally healthy, communicative adult. Patients and their families are cooperative, understanding, and supportive of this study.\n\nAdult patients undergoing VSD surgery for chronic wounds.\n\nExclusion Criteria:\n\n\\- Patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy.\n\nPatients with poor compliance or those who harbor skepticism and hostility towards this research.",{"count":114,"type":20},[23],"This study focuses on providing clinical care to patients undergoing VSD drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. It observes the influence of psychology on patients.",[27],[322,323,149],"VSD drainage surgery","systematic psychological intervention","2025-02-14",{"date":326,"type":32},"2025-02-17",{"date":328,"type":32},"2024-12-02",{"date":330,"type":20},"2026-12-31",{"name":332,"class":134},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine"]