[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venus-leg-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venus-leg-ulcer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645480","campr-ii-rwe-trial-a-saline-hydrated-allogeneic-dual-layer-amniotic-membrane-product-or-a-synthetic-resorbable-polymeric-wound-matrix-to-a-coarsened-exact-matched-retrospective-control-cohort-of-hard-to-heal-dfus-and-vlus-100645480",false,"NCT07701590","CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMPR-II","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. If a female is not currently pregnant or breastfeeding nor plans to become pregnant during the study and is either not of childbearing potential (defined as: postmenopausal \\[defined as amenorrhea for at least 1 year and serum follicle stimulating hormone (FSH) level \\>40 IU\u002FL\\], or surgically sterile \\[bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation at least 6 months prior to IP administration\\]), or is practicing one or more of the following medically acceptable methods of birth control throughout the study.\n\n   1. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's usual menstrual cycle period) before Screening\u002FRandomization Visit and must follow that product's package insert instructions including additional protection at times when hormonal contraceptive doses might be missed.\n   2. Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening\u002FRandomization Visit. Abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.\n   3. Intrauterine device\n   4. Vasectomized Partner (for at least 6 months)\n   5. Double-barrier method (condoms and clerical cap with spermicidal jellies or cream or condoms and diaphragm with spermicidal jellies or cream or condoms and contraceptive foam).\n3. Negative pregnancy test for all subjects of childbearing potential\n4. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration.\n5. No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n6. Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2\n7. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n8. Subject is able and willing to follow the protocol requirements\n9. Subject has signed informed consent.\n\nExclusion Criteria:\n\n1. Inability to adhere to the study protocol or study visit schedule\n2. Pregnancy\n3. Child-bearing potential without appropriate contraception\n4. Lactation\n5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.\n6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)\n7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety\n8. Known contraindications to the use of either IP1 or IP2\n9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.","ALL","18 Years",{"count":20,"type":21},147,"ESTIMATED","INTERVENTIONAL",[24],"NA","CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[27,28,29],"Wound, Foot","Diabetic Foot Ulcer (DFU)","Venus Leg Ulcer",[31,32,29,33],"DFU","VLU","Diabetic Foot Ulcer","RECRUITING","2026-07-13",{"date":37,"type":38},"2026-07-14","ACTUAL",{"date":40,"type":38},"2026-06-22",{"date":42,"type":21},"2026-12-20",{"name":44,"class":45},"Capsicure, LLC","NETWORK",7,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100641961","borate-based-bioactive-glass-fiber-matrix-bbgfm-in-the-treatment-of-venus-leg-ulcers-vlu-100641961","NCT07647705","Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)","A Phase IV, Post-market, Randomized, Controlled, Open-label, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of MIRRAGEN® Advanced Wound Matrix Plus Standard of Care Compared With Standard of Care Alone in Achieving Complete Wound Closure in Participants With Venous Leg Ulcers by 12 Weeks.","Inclusion Criteria:\n\nPatients are required to meet the following inclusion criteria before entering the study:\n\n1. Male or Female, 18 years of age or older\n2. Participant has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound. Venous etiology confirmed by duplex ultrasound of the affected limb performed within 90 days prior to randomization, demonstrating superficial and\u002For deep venous reflux (≥0.5 seconds) in the examined venous segments and no evidence of acute deep venous thrombosis.7, 8\n3. Participant has a venous leg ulcer present for ≥4 weeks and ≤18 months prior to screening, as documented in the medical record.\n4. The target wound must demonstrate ≤50% reduction in wound area following minimum of 28 consecutive days of continuous therapeutic compression at Randomization (Day 1).\n\n   a. For participants with clinical site medical records documenting a wound measurement, wound photography, and continuous therapeutic compression for \\>14 days prior to the Screening Visit, an accelerated 14-day screening period will be followed.\n\n   i. A documented wound measurement in medical record obtained \\>14 days prior to Screening Visit will serve as the reference measurement. The same wound measurement method (e.g., manual planimetry or a digital wound measurement system) must be used for all comparative assessments prior to randomization.\n\n   ii. At Screening Visit: The target wound must demonstrate ≤50% reduction in wound area following 14 consecutive days of SOC continuous therapeutic compression at screening compared with the reference measurement.\n\n   iii. At Randomization: After completion of a 14 day run in period of continuous therapeutic compression, the target wound must demonstrate ≤50% reduction at Randomization (Day 1) compared with the reference measurement (\\>28 days prior to randomization).\n\n   b. For participants without qualifying clinical site medical records, a traditional 28-day screening period will be followed.\n\n   i. The wound measurement obtained at Screening Visit will be the reference measurement.\n\n   ii. At Randomization: After completion of a 28 day run in period of continuous therapeutic compression, the target wound must demonstrate ≤50% reduction in wound area at Randomization (Day 1) compared with the reference measurement (\\>28 days prior to randomization).\n5. Target wound is between 2.0 cm² to ≤20.0 cm² at Randomization. Wound area will be measured at each visit using standardized digital planimetric measurement (standardized camera distance\u002Flighting and calibration); historical and screening percent area change calculations must use the same method.\n6. Adequate arterial perfusion demonstrated by one of the following:\n\n   * ABI ≥0.7 and ≤1.3 OR TBI ≥0.6, obtained within 30 days prior to randomization\n   * If ABI is \\>1.3 (noncompressible) or borderline, TBI or arterial duplex must be obtained to confirm adequate perfusion\n   * Tcom ≥40mmHg\n7. Target wound must be free of necrotic debris prior to application of MIRRAGEN® or standard of care (target wound bed is adequately debrided such that no adherent necrotic eschar or slough obscures wound bed assessment, and the wound is suitable for study product application per Investigator). 9, 10\n8. Females of childbearing potential must have a negative serum β-hCG at Screening, performed within 14 days prior to Randomization, and a negative urine pregnancy test at Randomization (Day 1) prior to receipt of study treatment. If the initial serum βhCG result is more than 14 days old at the time of Randomization, the serum β hCG test must be repeated to ensure it remains within the 14-day window.\n9. Target wound must be non-infected at Screening and Randomization. Non-infected is defined as absence of ≥2 local clinical signs (swelling\u002Finduration, erythema beyond margin, increased warmth, new\u002Fincreased pain\u002Ftenderness, or purulent exudate) and absence of systemic signs (fever or leukocytosis), consistent with Wound Healing Society (WHS) guidelines. Any infection present before or during the run-in period must be treated, and resolution must be documented prior to Randomization.\n10. If two or more wounds are present, the wounds must be separated by at least 2 cm.\n11. Participant has no more than 5 other wounds on the index leg.\n12. CEAP classification is not required as an eligibility criterion. Doppler waveform assessment (biphasic or triphasic signal) will not be used as an eligibility criterion. If there is more than one wound present, the largest qualifying wound will be the target wound.\n13. Participant is able and willing to follow the protocol requirements.\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any of the following exclusion criteria:\n\n1. Participant does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity.\n2. Participant has a known life expectancy of \\\u003C1 year.\n3. Participant is unable to comply with protocol treatment.\n4. Participant has comorbid conditions, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders. that may compromise participant's safety or wound healing in the opinion of the Investigator.\n5. Participant actively (or having a history) being treated for malignant disease, or history of malignancy or radiation therapy at the site of wound.\n6. HbA1c \\>12% (HbA1c must be ≤12% at screening, measured within 30 days prior to Randomization (Christman et al. 2011, Snyder et al. 2010), or renal failure defined as eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² (CKD stage 4-5) at Screening, or end-stage renal disease requiring dialysis).\n7. Known contraindications to bioabsorbable advanced wound matrix\n8. Concurrent participation in alternative clinical trial that involves investigational drug or cellular, acellular, and matrix-like products that may interfere with wound treatment and\u002For healing\n9. Participant is pregnant or breastfeeding.\n10. History of immunosuppressant treatment (systemic corticosteroids \\>10mg\u002F day), cytotoxic chemotherapy, or topical steroid application to the wound for \\>2 weeks within 30 days prior to Randomization, or anticipated use of any of the above during the course of the study\n11. Wound previously treated with cellular, acellular, or matrix-like products, tissue engineered constructs, or scaffold materials within 30 days prior to Randomization\n12. Wound depth with visible exposed bone or hardware\n13. Hyperbaric oxygen therapy (HBO) or Negative Pressure Wound Therapy (NPWT) within 28 days prior to Randomization\n14. Planned or recent (within 30 days prior to Screening) revascularization surgery\u002Fprocedure or venous intervention of the target wound limb, including arterial revascularization (endovascular or open bypass), or anticipated need for revascularization during the treatment period, as determined by vascular assessment\n\n    1. For arterial procedure: including but not limited to endovascular or open bypass\n    2. For venous procedures: including but not limited to endovenous ablation, surgical ligation\u002Fstripping, or perforator vein procedures\n15. Target wound suspicious of neoplasm in the opinion of the Principal Investigator\n16. Multiple venous leg ulcers on the same leg with \\\u003C2 cm² separation from the target wound\n17. Inability to tolerate the protocol-approved compression therapy\n18. Stage II or Stage III lymphedema as defined by the Society of Lymphology\n19. Body mass index (BMI) \\>45 kg\u002Fm² at Screening. Participants with BMI \\>45 kg\u002Fm² will be excluded due to the potential for impaired mobility, difficulties with consistent application or tolerance of therapeutic compression, and increased risk of confounding factors that may adversely affect venous leg ulcer healing.",{"count":55,"type":21},110,[24],"The goal of this clinical trial is to learn if Borate-based Bioactive Glass Fiber Matrix (BBGFM) can help heal Venous Leg Ulcers (VLU) that have not closed with standard treatment. The main question it aims to answer is:\n\n1\\. Does BBGFM help Venus Leg Ulcers heal completely in 12 weeks?\n\nResearchers will compare BBGFM plus Standard of Care (SOC) to SOC alone to see if BBGFM works to heal wounds.\n\nParticipants will:\n\n* Have BBGFM applied to their wound (if assigned to the BBGFM group) for up to 12 applications\n* Visit the clinic each week for wound checks and tests\n\nOther study purposes include looking at:\n\n* The time it takes for the wound to heal\n* Changes in wound size over time\n* The durability of wound healing after closure\n* The use of healthcare resources related to wound care\n* Any adverse events (side effects) or reactions related to the treatment\n* Changes in pain levels\n* Changes in quality of life",[59,32,29,60],"Venus Leg Ulcer (VLU)","Venus Ulcer",[62,63,64],"Mirragen","BBGFM","Borate-base Bioactive Glass Fiber Matrix","NOT_YET_RECRUITING","2026-06-10",{"date":68,"type":38},"2026-06-15",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2028-01",{"name":74,"class":75},"ETS Wound Care, LLC","INDUSTRY"]