[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-ulcers-dfus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-ulcers-dfus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,56,84,112,143,175,203,227,291],{"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":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100643797","miro3d-wound-matrix-for-treatment-of-diabetic-foot-ulcers-100643797",false,"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.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29],"Diabetic Foot Ulcers (DFUs)","Diabetic Foot","Chronic Wounds",[31,32,33,34,35,36,37,38,39,40,41,42],"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","RECRUITING","2026-06-03",{"date":46,"type":47},"2026-06-08","ACTUAL",{"date":49,"type":21},"2026-06",{"date":51,"type":21},"2027-05",{"name":53,"class":54},"Reprise Biomedical, Inc.","INDUSTRY",14,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100636424","phase-2-phase-2a-dose-finding-study-of-nu-3-gel-in-subjects-with-mild-idfu-100636424","NCT07565506","Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU","A Prospective, Randomized, Single-Blind Phase 2a Multi-Center Dose Comparative Study to Evaluated The Safety, Tolerability, and Antimicrobial Efficacy Of Topically Twice Daily Applied Bisphosphocin Nu-3 Gel At a 2%, 5%, And 10% Concentration To Infected Diabetic Foot Ulcers (iDFU)","Inclusion Criteria:\n\n1. Male and female subjects ≥18 years of age.\n2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable.\n3. Non-hospitalized ambulatory subjects diagnosed with diabetes mellitus, Type I or II per ADA criteria with signs of a localized mild foot infection as defined by the IDSA infection severity criteria (Lipsky,2012). The presence of purulent drainage or at least two of the following criteria:\n\n   i. erythema, ii. warmth, iii. pain or tenderness, iv. edema, or v. induration (The diagnosis of mild infection must be confirmed immediately following debridement at Baseline).\n4. The target ulcer is classified as a grade 1 ulcer according to the Wagner Scale (Wagner 1979). The ulcer is a superficial, full-thickness ulcer limited to the dermis, not extending to the subcutis. Target ulcer is \\>1 cm2 and \\\u003C12 cm2 post debridement at baseline and must be no higher than the ankle, on or below the malleolus (ankle bone) with ≥50% below the malleolus.\n5. Adequate vascular perfusion as evidenced by one of the following:\n\n   1. Dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 40 mmHg\n   2. Ankle Branchial Index (ABI) between 0.9 and 1.3 within 3 months of Screening using the extremity with the target ulcer.\n   3. Arterial Doppler ultrasound evaluating for biphasic or triphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \\>0.75.\n6. Subject has a caregiver who will attend the Baseline visit (V2) and\u002For watch the dosing and dressing demonstration video and apply wound treatment along with study dressings for the study duration.\n7. Must meet one of the following criteria:\n\n   a. Female subjects of Non-Child-Bearing Potential i. Postmenopausal for at least 1 year ii. Surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to Screening) iii. Bilateral tube ligation \\> 6 months prior to screening iv. A negative serum β-hCG pregnancy test at screening and no breastfeeding after the administration of the study drug.\n\n   b. Male subjects of Non-Childbearing Potential defined as: i. Vasectomized subjects for \\> 6 months prior to Screening ii. Those diagnosed as sterile by a physician. c. Females and Males of Childbearing Potential who practice an acceptable method of contraception defined as the i. Use of any form of hormonal contraceptive ii. Use of a barrier method with spermicide, condoms, intrauterine device, iii. Abstinence from sexual intercourse starting at least 60 days prior to Screening and continuing at least 14 days following the last treatment.\n8. Subjects must be willing to undergo all clinical investigation-related procedures, attend all required visits, and cooperate fully with the investigator and site personnel.\n9. Subject must be willing to wear offloading RCW, if necessary (defined as ulcer at plantar site of the foot, see Appendix 6), throughout the duration of the clinical treatment.\n10. Subject must have plain radiograph taken at screening and prior to randomization showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.\n\nExclusion Criteria:\n\n1. Ulceration with exposed tendon, capsule, or bone\n2. IDSA-defined moderate or severe DFU infection.\n3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.\n4. \\> 1 infected foot ulcer\n5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer or received such topical antimicrobial treatment \\\u003C 72 hours prior to study enrollment.\n6. Subject has received systemic treatment with a long-lasting antibiotic such as azathioprine (within less than 10 days prior to Screening) or any other systemic antibiotic within 48 hours prior to Screening.\n7. Concurrent or expected to require systemic antimicrobials during the active treatment study period for any infection including diabetic foot ulcer.\n8. Any subject that has active viral hepatitis (A, B, C) and\u002For untreated HIV\u002FAIDS.\n9. Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation\n10. eGFR \\\u003C60 and\u002For subject on hemodialysis within 3 months prior to randomization.\n11. Hemoglobin A1c (HbA1c) \\>12% within 3 months prior to randomization.\n12. Aspartate Aminotransferase (AST, GOT) and\u002For Alanine Aminotransferase (ALT, GPT) \\>3.0 x the upper limit of normal and\u002For bilirubin \\>1.5 x the upper limit of normal within 3 months prior to randomization.\n13. Acute active Charcot foot\n14. Any subject that would be unable to safely monitor the infection status at home and return for scheduled visits.\n15. History of immunosuppression within 3 months prior to randomization, or taking immunosuppressive agents including systemic corticosteroids, except stable daily doses of 5 mg\u002Fday or less for chronic conditions\n16. Any subject with a life expectancy ≤ 6 months\n17. Use of investigational drugs within 28 days prior to screening\n18. Use of Aspirin® or acetylsalicylic acid containing medication (except low-dose aspirin) \\\u003C 7 days before baseline,\n19. Use of oral anticoagulants (e.g., warfarin, Xarelto® or comparable products).\n20. History of concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol including known or suspected active abuse of alcohol, narcotics, or non-prescription drugs.\n21. Prior randomization in this clinical trial, or a previous Bisphosphocin study",{"count":64,"type":21},24,[66],"PHASE2","The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3. The main questions it aims to answer are:\n\nDoes drug Nu-3 lower the number of bacteria or viruses in the infected ulcer, or cure patients of the infection, at any or all of the dose levels being tested after 1 week or 2 weeks? What medical problems do participants have when taking the topical drug Nu-3? Researchers will compare drug Nu-3 at different dose levels to see if drug Nu-3 works to treat the infected ulcers at each of the dose levels.\n\nParticipants will:\n\nTake drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler",[27],[70,71,72,73],"diabetic foot ulcer","infection","mildly infected diabetic foot ulcer","iDFU","NOT_YET_RECRUITING","2026-04-27",{"date":77,"type":47},"2026-05-04",{"date":79,"type":21},"2026-08",{"date":81,"type":21},"2026-12",{"name":83,"class":54},"Lakewood-Amedex Inc",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100626693","a-study-on-the-efficacy-and-safety-of-a-nitric-oxide-generating-dressing-in-the-treatment-of-diabetes-related-foot-ulcers-100626693","NCT07438951","A Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing in the Treatment of Diabetes Related Foot Ulcers.","A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).","ONWARD","Inclusion Criteria:\n\nIC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study\n\nIC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:\n\nIC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer\n\nIC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.\n\nOnly PEDIS 2 infections are permitted - Mild superficial skin and soft tissue infections with no systemic manifestations and involving:\n\n• Erythema extending ≥2 cm from the wound margin, and\u002For tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone)\n\nIC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;\n\n1. Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND\n2. Ankle Brachial Index (ABI) \\>0.6 OR Toe Brachial Index (TBI) \\>0.5, OR\n3. Toe pressure \\>40mmHg\n\nExclusion Criteria:\n\nEC-1 Ulcers that are tunnelling or have cavities (\\>10mm in depth)\n\nEC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped\n\nEC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids \\\u003C10mg\u002Fkg\u002Fday is permitted\n\nEC-4 Active Charcot foot",{"count":93,"type":21},102,"OBSERVATIONAL","Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers",[27],[98,99,100,101,102],"Diabetic foot ulcers","Nitric Oxide","Wound","dressing","Woundcare","2026-03-16",{"date":105,"type":47},"2026-03-18",{"date":107,"type":21},"2026-07",{"date":109,"type":21},"2027-09",{"name":111,"class":54},"ConvaTec Inc.",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100588306","miro3d-wound-matrix-study-for-diabetic-foot-ulcers-and-wound-healing-100588306","NCT06939686","Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing","A Randomized Controlled Trial Evaluating Reprise Biomedical's Miro3D Wound Matrix and Standard of Care Versus Standard of Care Alone in Treating Wagner Grade 1 Diabetic Foot Ulcers and Dehiscence","STRIDDDE","Inclusion Criteria:\n\n1. Must be at least 18 years of age and capable of providing informed consent.\n2. Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus.\n3. Index wound\u002Fulcer must be between 1 cm² and 20 cm² post-debridement.\n4. Wound\u002Fulcer must have been present for at least 4 weeks prior to screening.\n5. Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic\u002Fbiphasic Doppler waveforms.\n6. Other wounds, if present, must be at least 2 cm from the index wound\u002Fulcer.\n7. Any previous infections must have been adequately treated per IDSA guidelines.\n8. Subjects must agree to proper offloading and\u002For compression, have a stable living environment, and be able to attend follow-up visits.\n9. Must provide written consent for digital imaging.\n10. For Miro3D arm: Index wound\u002Fulcer must have a clean base free of devitalized tissue or debris at the time of product placement.\n\nExclusion Criteria:\n\n1. Index wound\u002Fulcer has reduced ≥30% after two weeks of SOC from screening to baseline.\n2. Poorly controlled diabetes (HbA1c ≥ 12%).\n3. Active, untreated or uncontrolled osteomyelitis.\n4. Malignancy or vasculitis at the wound site.\n5. Undergoing chemotherapy.\n6. On dialysis.\n7. Use of investigational drugs or therapies within 30 days prior to screening.\n8. Conditions that would compromise study participation or adherence.\n9. Known sensitivity to porcine materials.\n10. Third-degree burns.\n11. Worsening ischemia or gangrene at screening.\n12. History of radiation to the wound site.\n13. Exposed internal fixation, implants, or hardware in the wound.\n14. Patient is transitioning to palliative or comfort care.",{"count":121,"type":21},30,[24],"This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and wound dehiscence in an outpatient setting. The trial is sponsored by Reprise Biomedical, Inc. and aims to explore whether the addition of Miro3D-a three-dimensional, acellular porcine-derived wound matrix-enhances wound healing outcomes compared to SOC alone.\n\nPurpose of the Study: The primary purpose of the study is to determine whether applying Miro3D in combination with SOC leads to improved healing of diabetic foot ulcers compared to SOC alone. Specifically, the study seeks to assess early wound healing progress at four weeks (as measured by percent area reduction and granulation tissue formation) as a predictor of complete healing by twelve weeks.\n\nKey Question the Study Seeks to Answer: Does the addition of Miro3D to standard wound care improve the healing rate and overall wound outcomes for patients with Wagner Grade 1 diabetic foot ulcers or dehisced wounds compared to standard care alone?\n\nStudy Design Overview: Subjects who meet inclusion\u002Fexclusion criteria will be randomized into one of two groups:\n\n1. Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks.\n2. SOC alone (control) arm - receiving SOC without Miro3D. If the wound remains unhealed at 12 weeks in the SOC alone arm, participants may \"crossover\" to receive Miro3D treatment under the same schedule for an additional 12 weeks.\n\nPrimary Endpoint:\n\n1\\. Percent Area Reduction (PAR) and granulation tissue formation at 4 weeks, serving as predictors for wound healing at 12 weeks.\n\nSecondary Endpoints:\n\n1. Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound\u002FUlcer-QOL tool.\n2. Pain levels using a Visual Analog Scale (VAS) at each visit.\n\nPopulation: Approximately 30 adult subjects (15 per arm) with Wagner Grade 1 diabetic foot ulcers or dehisced wounds will be enrolled. Subjects must have adequate blood flow, demonstrate wound size criteria, and commit to offloading and follow-up care.\n\nFollow-Up: Subjects will be followed weekly through the 12-week study period. Healed subjects will undergo confirmation visits at 2 and 4 weeks post-closure. Subjects in the crossover arm will be followed for an additional 12 weeks if their wound was unhealed at the primary endpoint.\n\nStatistical Considerations: Data will be summarized using descriptive statistics, including wound measurements, infection status, and healing rates. Comparative analysis will be conducted between treatment groups and schedules (weekly vs. biweekly Miro3D application). Adverse events (AEs), serious adverse events (SAEs), and device-related events will also be documented.\n\nThis study aims to generate clinical evidence supporting the use of Miro3D as a beneficial adjunct to standard wound care in promoting early and complete healing of diabetic foot ulcers.",[27,125],"Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)",[35,36,127,128,129,130,131,132,133],"Miro3D Wound Matrix","Acellular Wound Scaffold","Porcine-derived Wound Matrix","Biologic Wound Matrix","Wound Granulation","Percentage Area Reduction","Reprise Biomedical","2025-12-22",{"date":136,"type":47},"2025-12-24",{"date":138,"type":47},"2024-11-01",{"date":140,"type":21},"2026-07-31",{"name":53,"class":54},3,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":159,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"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":151,"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.",[27,155,156,157,29,158],"Venous Leg Ulcers (VLUs)","Pressure Ulcers","Surgical Wound Dehiscence (SWD)","Undermined and Tunneling Wounds",[127,160,161,36,162,163,164,165,166,167,133],"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",{"date":136,"type":47},{"date":170,"type":47},"2024-02-29",{"date":172,"type":21},"2025-12-31",{"name":53,"class":54},2,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":186,"conditions":187,"keywords":192,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"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":183,"type":21},600,[185],"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.",[29,155,27,188,156,189,190,191],"Arterial Ulcers","Burn Wounds","Trauma Wounds","Surgical Wounds",[193],"chronic wounds","2025-11-04",{"date":196,"type":47},"2025-11-06",{"date":198,"type":21},"2026-01-01",{"date":200,"type":21},"2028-03",{"name":202,"class":54},"Bardia Anvar",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100607168","evaluation-of-the-clinical-efficacy-and-feasibility-of-digital-foot-care-intervention-strategies-with-different-intensities-in-the-prevention-of-diabetic-foot-ulcers-100607168","NCT07185048","Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.","Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention","Inclusion Criteria:\n\n1. Age ≥ 50 years but \\\u003C 80 years;\n2. Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);\n3. Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;\n4. Willing to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Currently has an open foot wound or an unresolved foot ulcer;\n2. History of major lower limb amputation above the ankle joint;\n3. Pregnancy or breastfeeding;\n4. Currently suffering from poorly controlled malignant tumors;\n5. Receiving glucocorticoid or immunosuppressive therapy;\n6. Diagnosed with vascular occlusive vasculitis;\n7. Presence of foot fracture;\n8. Significant visual impairment affecting image acquisition or operation;\n9. Other conditions deemed inappropriate for participation in this study by the research team.","50 Years","80 Years",{"count":213,"type":21},1512,[24],"For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.",[27],"2025-09-15",{"date":219,"type":47},"2025-09-22",{"date":221,"type":21},"2025-10",{"date":223,"type":21},"2028-09",{"name":225,"class":226},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":235,"targetDuration":237,"studyType":94,"phases":4,"briefSummary":238,"conditions":239,"keywords":256,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":290},"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":236,"type":21},300000,"5 Years","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.",[28,240,241,242,243,244,245,246,247,248,155,249,250,251,27,252,188,253,254,255],"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",[257,258,259,260,193,261,35,262,240,252,263,264,248,265,37,266,267,268,269,270,271,272,273,274,275,276,277,278,279,42,280],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic ulcers","Venous Leg Ulcer","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","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)","Standard of Care","2025-07-10",{"date":283,"type":47},"2025-07-16",{"date":285,"type":47},"2005-01-01",{"date":287,"type":21},"2030-01",{"name":289,"class":226},"U.S. Wound Registry",1,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":290},"100575070","clinical-trial-evaluating-an-amnion-membrane-allograft-for-use-in-the-management-of-non--healing-diabetic-foot-ulcers-versus-standard-of-care-100575070","NCT06767501","Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care","A Randomized Controlled Clinical Trial Evaluating The Efficacy of an Amnion Membrane Allograft Intended for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care Alone","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older.\n2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.\n3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement with manual measurement.\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 located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone.\n7. 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.\n8. 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.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization.\n10. The subject must consent to using the prescribed off-loading method for the duration of the study.\n11. The subject must agree to attend the weekly study visits required by the protocol.\n12. The subject must be willing and able to participate in the informed consent process.\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 foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n8. If a subject 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. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.\n12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n13. A potential subject with end stage renal disease requiring dialysis is excluded.\n14. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n15. 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":299,"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 Standard of Care (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* Changes in neuropathy (nerve damage)\n* Change in pain levels\n* Occurrence of infection",[27],"2025-01-08",{"date":305,"type":47},"2025-01-10",{"date":307,"type":47},"2024-12-28",{"date":309,"type":21},"2025-12",{"name":311,"class":54},"Skye Biologics Holdings, LLC"]