[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vlu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vlu":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,84],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100641961","borate-based-bioactive-glass-fiber-matrix-bbgfm-in-the-treatment-of-venus-leg-ulcers-vlu-100641961",false,"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.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"NA","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",[26,27,28,29],"Venus Leg Ulcer (VLU)","VLU","Venus Leg Ulcer","Venus Ulcer",[31,32,33],"Mirragen","BBGFM","Borate-base Bioactive Glass Fiber Matrix","NOT_YET_RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":20},"2026-07",{"date":42,"type":20},"2028-01",{"name":44,"class":45},"ETS Wound Care, LLC","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100628571","phase-1-lut017-gel-for-venous-leg-ulcers-and-chronic-non-healing-skin-wounds-in-adults-100628571","NCT07463365","LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults","A Phase 1, Open-Label Clinical Trial to Assess the Safety, Tolerability, and Preliminary Efficacy Study of Topically Administered LUT017 Gel for Cutaneous Wound Healing","Inclusion Criteria\n\n1. Subjects with venous leg ulcers (VLU), defined by open skin lesion of the leg as a result of venous hypertension.\n2. Subject must be ≥ 18 years of age.\n3. Active lower extremity ulceration (CEAP classification of C6).\n4. Non-healing VLU ≥ 4 weeks but not greater than 24 months.\n5. Ulcer size ≥ 2cm2 ≤ 20cm2.\n\n   a. Target ulcer will be defined as the largest ulcer on the affected limb. Only one wound per subject will be designated as the study wound and treated with the investigational gel. If a subject has two wounds separated by less than 1 cm of intact skin, these wounds will be considered a single study wound, and the surface areas of both wounds will be added together for eligibility purposes; if the combined area exceeds 20 cm², the subject will be excluded from the study. Although only one wound will be directly treated, local activation of the MAPK pathway may result in biological stimulation of the adjacent untreated wound when wounds are separated by less than 1 cm.\n6. Chronic venous insufficiency confirmed by ultrasound within previous 12 months.\n7. Adequate perfusion confirmed within the past 12 months.:\n\n   1. Dorsalis Pedis (DP) or Posterior Tibial (PT) systolic pressure ≥ 60mmHg on the study limb.\n   2. Transcutaneous partial pressure oxygen (TcP02) \\> 30mmHg.\n   3. Great toe systolic pressure \\> 40mmHg.\n8. Must be able and willing to provide informed consent prior to study participation.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0). They should agree to use highly effective methods of birth control, defined as those with failure less than 1%, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUD's), sexual abstinence, or a vasectomized partner. Such subjects should agree to have monthly pregnancy test documented.\n\nExclusion Criteria\n\n1. Target ulcer has exposed of tendon, muscle, or bone.\n2. Target ulcer is of non-venous etiology.\n3. Target ulcer has been treated with living cellular therapy within 4 weeks of the randomization.\n4. Target ulcer shows any signs of infection (only non-infected ulcers are eligible).\n5. Patient has undergone endovenous ablation or other venous surgery within 4 weeks of enrollment.\n6. Unable to tolerate multi-layer bandages or compression garments.\n7. Decompensated congestive heart failure within 4 weeks of screening.\n8. Active soft tissue or bone infection requiring antibiotics.\n9. Skin cancer on the target limb within the last 24 months.\n10. Actively receiving chemotherapy and\u002For radiation therapy for cancer.\n11. Treatment with a serine\u002Fthreonine-protein kinase BRAF inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib) or Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer.\n12. Blood chemistry or counts values as follows:\n\n    1. White Blood Cells (WBC)\\\u003C 1.5 x 109\u002FL.\n    2. Absolute \\\u003C 0.9 x 109\u002FL.\n    3. Platelet count \\\u003C 50 x 109\u002FL.\n    4. Alanine aminotransferase \\> 3 x upper limit of normal.\n    5. Aspartate aminotransferase \\> 3 x upper limit of normal.\n    6. Serum albumin \\\u003C2.0 g\u002FdL.\n    7. HbA1c value of \\> 12% within the past three (3) months.\n13. Current use of systemic corticosteroids \\> 5 mg daily or equivalent within 4 weeks.\n14. Currently pregnant or trying to become pregnant.\n15. Inability or unwillingness to participate in all aspects of study protocol or as determined by the Investigator.\n16. Known hypersensitivity to the ingredients of the study drug.",{"count":54,"type":20},18,[56],"PHASE1","This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with conditions like diabetes or obesity.\n\nLUT017 is a gel that will be applied directly to the surface of these wounds. The goal of the study is to find out if the gel is safe and well tolerated when applied once a week for up to 8 weeks. The researchers will also look for early signs of whether the gel helps the wounds heal more quickly or completely. The gel contains a medicine that has been shown in animal studies to activate natural skin repair processes and promote cell growth, potentially speeding up the healing process.\n\nThe study will involve between 12 and 18 adult participants who have had a chronic leg wound for at least 4 weeks. All participants will go through a screening process to make sure they are eligible. If they qualify, they will first complete a two-week \"run-in\" phase where their wound will be treated with standard medical bandages. This phase helps ensure that only participants whose wounds are not healing with normal care are included.\n\nIf participants remain eligible after this period, they will start the treatment phase. During this phase, they will come to the clinic once a week for 8 weeks to receive the LUT017 gel treatment directly on their wound. Each visit will include a physical exam, vital signs, wound evaluation, photographs of the wound, and blood tests to monitor safety.\n\nAfter the 8-week treatment period, participants will return for two follow-up visits-one at 3 months and one at 6 months after their first treatment. These visits will help the researchers understand how long any benefits of the treatment might last and monitor for any delayed side effects.\n\nIn total, participants will be involved in the study for about 6.5 months and will have approximately 12 to 14 visits to the clinic. Participation is entirely voluntary, and individuals can withdraw at any time. The research team is committed to ensuring participant safety and privacy throughout the study.",[59,60,27],"Venous Leg Ulcer","Chronic Non-Healing Cutaneous Wounds",[59,62,63,64,65,66,67,68,69,70,71,72],"Chronic Wound Healing","Topical BRAF Inhibitor","LUT017","Paradoxical MAPK Activation","Epidermal Regeneration","Cutaneous Wound Healing","Phase 1 Clinical Trial","Dose Escalation Study","Re-epithelialization","Dermatologic Regenerative Therapy","Local MAPK Activation","2026-05-26",{"date":75,"type":38},"2026-05-29",{"date":77,"type":20},"2026-10-02",{"date":79,"type":20},"2027-06",{"name":81,"class":82},"Antoni Ribas","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":83},"100569721","evaluating-the-durability-of-closure-for-venous-leg-ulcers-100569721","NCT06697925","Evaluating the Durability of Closure for Venous Leg Ulcers","Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial","THORSDOTTIR","Inclusion Criteria:\n\n* 1\\. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.\n\nExclusion Criteria:\n\n* 1\\. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.",{"count":93,"type":20},150,"OBSERVATIONAL","The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.",[97,98,59,99,27],"Venous Leg","Venous Leg Ulcer (VLU)","Venous Ulcer","RECRUITING","2025-01-22",{"date":103,"type":38},"2025-01-24",{"date":105,"type":20},"2025-01",{"date":107,"type":20},"2026-12",{"name":109,"class":45},"Kerecis Ltd."]