[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570427":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":173,"collaborators":31,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":31,"enrollmentInfo":185,"targetDuration":31,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":201,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"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",[39,53,58,69,79,94,105,116,127,139,150,161],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":31},"Clincial Research Site 92","RECRUITING","Jacksonville","Florida","32256","United 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Research Site 60","Ivanhoe","3079",{"type":48,"coordinates":144},[145,146],145.04308,-37.76903,{"lat":146,"lon":145},[149],{"name":31,"role":35,"phone":31,"phoneExt":31,"email":93},{"facility":151,"status":41,"city":152,"state":130,"zip":153,"country":84,"countryCode":85,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Clincial Research Site 65","Shepparton","3630",{"type":48,"coordinates":155},[156,157],145.39867,-36.38047,{"lat":157,"lon":156},[160],{"name":31,"role":35,"phone":31,"phoneExt":31,"email":93},{"facility":162,"status":60,"city":163,"state":164,"zip":165,"country":84,"countryCode":85,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Clincial Research Site 75","Nedlands","Western Australia","6009",{"type":48,"coordinates":167},[168,169],115.8073,-31.98184,{"lat":169,"lon":168},[172],{"name":31,"role":35,"phone":31,"phoneExt":31,"email":93},{"type":174,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100570427","phase-3-tissue-repair-gel-in-venous-leg-ulcers-in-auus-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":186,"type":187},312,"ESTIMATED","INTERVENTIONAL",[190],"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.",[193,194,195,196,197,198,199,200],"Venous Leg Ulcer","Venous Ulcer","Venous Stasis Ulcer","Venous Stasis","Wound Heal","Wound","Venous Insufficiency of Leg","Non-healing Wound",[202,26,5,203,204],"Tissue Repair","Debridement","VLU","2025-03-27",{"date":207,"type":208},"2025-04-02","ACTUAL",{"date":210,"type":187},"2025-04",{"date":212,"type":187},"2027-02",{"name":5,"class":6},12]