[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-wound-of-the-lower-limb-leg-ulcer-or-foot-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-wound-of-the-lower-limb-leg-ulcer-or-foot-ulcer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,85],{"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":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100588306","miro3d-wound-matrix-study-for-diabetic-foot-ulcers-and-wound-healing-100588306",false,"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.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"Diabetic Foot Ulcers (DFUs)","Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)",[30,31,32,33,34,35,36,37,38],"Diabetic Foot Ulcer","Chronic Wound Healing","Miro3D Wound Matrix","Acellular Wound Scaffold","Porcine-derived Wound Matrix","Biologic Wound Matrix","Wound Granulation","Percentage Area Reduction","Reprise Biomedical","RECRUITING","2025-12-22",{"date":42,"type":43},"2025-12-24","ACTUAL",{"date":45,"type":43},"2024-11-01",{"date":47,"type":21},"2026-07-31",{"name":49,"class":50},"Reprise Biomedical, Inc.","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100585188","correlating-multispectral-near-infrared-imaging-to-standard-vascular-diagnostics-100585188","NCT06899113","Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 and older\n* Patient is undergoing an ABI test.\n* Patient recently had\u002Fwill have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)\n* Patients who can be followed by the same investigating team for the whole period of their participation in the study.\n\nExclusion Criteria:\n\n* Patients who are participating in another clinical study for ulcer management\n* Patients who are unable to understand the aims of the study and not able to provide informed consent\n* Receiving radiation to the extremity\n* Active charcot joints",{"count":58,"type":21},60,"OBSERVATIONAL","The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment.\n\nThe main questions it aims to answer are:\n\n* Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms?\n* Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage?\n* Is the MIMOSA Pro able to measure vascular status more often than other modalities?\n\nParticipants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.",[62,28],"Vascular Disease, Peripheral",[64,65,66,67,68,69,70,71,72,73,74],"multispectral near-infrared spectroscopy","chronic wound","peripheral vascular disease","near-infrared imaging","ABI","tissue oxygenation","tissue oximetry","TBI","TCOM","TcPO2","Doppler","2025-09-10",{"date":77,"type":43},"2025-09-11",{"date":79,"type":43},"2025-05-13",{"date":81,"type":21},"2025-12",{"name":83,"class":50},"MIMOSA Diagnostics Inc.",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100578394","phase-2-evaluate-use-of-tropocellsr-autologous-platelet-rich-fibrin-prf-for-wagner-grade-1-and-grade-2-mild-to-mod-neuroischemic-plantar-diabetic-foot-ulcer-wound-care-100578394","NCT06810726","Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.","EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age\n2. Type 1 or Type 2 Diabetes\n3. Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day\n4. Ulcer Size 1.0 cm2 to 12.0 cm2\n5. Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm\n6. If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.\n7. At least 2.0 cm between the index wound and other wounds.\n8. Study ulcer has been present for at least 30 days and has undergone the 14-day\n9. Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.\n10. WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)\n11. Screening Period of the standard of care with 20% or less wound closure.\n12. No Clinical Signs of Infection at the wound site or the affected limb.\n13. Post-debridement without signs of necrotic tissue.\n14. Normal Platelet count ≥ 105,000 and \\\u003C450, 000 (according to CBC)\n15. Hemoglobin (Hgb) ≥10 g\u002FdL and Hematocrit (HCT) ≥ 27% (according to CBC)\n16. Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist\n17. No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15\n18. PT\u002FPTT - INR between 2.0-3.0 (with blood thinners).\n19. Nutritional Status with no severe protein deficiency, Pre-albumen \\>15 mg\u002FdL\n20. Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).\n21. If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.\n22. Male subjects agree to use contraception or abstinence during the trial.\n23. The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.\n\nExclusion Criteria:\n\n1. Life expectancy is less than 12 months.\n2. Anemia Hgb ≤ 10 g\u002FdL and HCT ≤ 27%.\n3. Ulcers of other than diabetic foot pathophysiology.\n4. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.\n5. Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.\n6. Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.\n7. Osteomyelitis at the designated wound site; using ESR ≥ and \u002For CRP ≥ 7.9 mg\u002Fd as a screen.\n8. CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.\n9. Religious constraints to using blood products, including autologous blood.\n10. Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.\n11. Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).\n12. Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.\n13. The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.\n14. The subject is undergoing hemodialysis.\n15. Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.\n16. Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.\n17. History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.\n18. Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.\n19. Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.\n20. Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.\n21. Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.\n22. Received radiation therapy or chemotherapy within the previous 3 months.\n23. Subjects with known sensitivity to blood components such as those in the PRF kit.\n24. The subject has inadequate venous access for repeated blood draws required for the PRP preparation.","80 Years",{"count":20,"type":21},[95],"PHASE2","The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nMeasure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group.\n\nRun-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care.\n\nActive Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System.\n\nFollow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.",[30,98,99,100,28,101],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus (T2DM)","Neuroischemic Foot Ulcer","Chronic Wound Care",[103,104,105,106,101],"PRF used for Wagner Grade 2 DFU","Tropocells Platelet-rich Fibrin","Platelet-rich Plasma (PRP)","Platelet-derived Factors for wound care","2025-06-10",{"date":109,"type":43},"2025-06-12",{"date":111,"type":43},"2025-04-15",{"date":113,"type":21},"2026-08-15",{"name":115,"class":50},"Estar Medical dba Medical Technologies, LTD",2]