[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570427":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":171,"collaborators":31,"id":173,"slug":31,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":31,"enrollmentInfo":182,"targetDuration":31,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":198,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"TR Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TR987 0.1% gel + Standard of Care","EXPERIMENTAL","Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing\u002Fdressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.",[13],"Drug: TR987 0.1% gel + Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","OTHER","Participants will receive Standard of Care (wound cleansing\u002Fdressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks.",[19],"Other: Standard of care",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","6mg topical gel for application plus Standard of Care (wound cleansing\u002Fdressings and compression bandaging)",[9],[26],"Glucoprime",{"type":16,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard of care","Standard of Care (wound cleansing\u002Fdressings and compression bandaging)",[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Anhthu Nguyen Vice President, Global Clinical Operations","CONTACT","(+61) 280 034 554","anhthu.nguyen@trtherapeutics.com",[39,52,57,68,78,92,103,114,125,137,148,159],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":31},"Clincial Research Site 92","RECRUITING","Jacksonville","Florida","32256","United 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65","Shepparton","3630",{"type":47,"coordinates":153},[154,155],145.39867,-36.38047,{"lat":155,"lon":154},[158],{"name":31,"role":35,"phone":31,"phoneExt":31,"email":91},{"facility":160,"status":59,"city":161,"state":162,"zip":163,"country":83,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Clincial Research Site 75","Nedlands","Western Australia","6009",{"type":47,"coordinates":165},[166,167],115.8073,-31.98184,{"lat":167,"lon":166},[170],{"name":31,"role":35,"phone":31,"phoneExt":31,"email":91},{"type":172,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100570427",false,"NCT06707103","Tissue Repair Gel in Venous Leg Ulcers in AU\u002FUS","A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)","TRIVIA","Inclusion Criteria:\n\n* Adults 18 years and older\n* Venous insufficiency has been clinically diagnosed clinically and medically confirmed.\n* Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.\n* The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.\n* Target ulcer age must be ≥ 4 weeks at Screening.\n* Participants must have adequate arterial flow as confirmed by ABI\u002FTBI, TB, SPP, TCPo2, or Duplex Doppler.\n* Body mass index (BMI) ≤ 50 kg\u002Fm2.\n* HbA1C ≤12%.\n\nExclusion Criteria:\n\n* Target ulcer has been treated with prohibited medications or therapies.\n* History of radiation at the target ulcer site.\n* Target ulcer decreases in area by 30% or more during screening period.\n* History of osteomyelitis at the target ulcer within 6 months of screening.\n* History of cancer in the preceding 5 years (except as noted in the protocol).\n* Participants considered nutritionally deficient.","ALL","18 Years",{"count":183,"type":184},312,"ESTIMATED","INTERVENTIONAL",[187],"PHASE3","The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.",[190,191,192,193,194,195,196,197],"Venous Leg Ulcer","Venous Ulcer","Venous Stasis Ulcer","Venous Stasis","Wound Heal","Wound","Venous Insufficiency of Leg","Non-healing Wound",[199,26,5,200,201],"Tissue Repair","Debridement","VLU","2025-03-27",{"date":204,"type":205},"2025-04-02","ACTUAL",{"date":207,"type":184},"2025-04",{"date":209,"type":184},"2027-02",{"name":5,"class":6},12]