[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596538":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":165,"collaborators":167,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":173,"sex":179,"minAge":180,"maxAge":12,"enrollmentInfo":181,"targetDuration":12,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":44,"whyStopped":12,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Capsicure, LLC","NETWORK",[8,13,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","NO_INTERVENTION","This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group.\n\nSubjects will be randomized to one of two interventions:\n\nIP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap\n\nSubjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)",null,{"label":14,"type":15,"description":11,"interventionNames":16},"IP1: BioLab Membrane Wrap Lite","EXPERIMENTAL",[17],"Other: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap",{"label":19,"type":15,"description":11,"interventionNames":20},"IP2: BioLab Tri-Membrane Wrap",[21],"Other: IP2: BioLab Tri-Membrane Wrap",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":12},"OTHER","IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap","BioLab Membrane Wrap LiteTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Membrane Wrap LiteTM is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \\[Human Cellular and Tissue Based Product (HCT\u002FP)\\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.",[14],{"type":24,"name":19,"description":29,"armGroupLabels":30,"otherNames":12},"BioLab Tri-Membrane WrapTM is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. Tri-Membrane WrapTM is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \\[Human Cellular and Tissue Based Product (HCT\u002FP)\\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.",[19],[32],{"name":33,"affiliation":5,"role":34},"Windy Cole, DPM","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":12,"email":40},"Marissa Docter, RN, BSN, MD","CONTACT","512-571-2966","mdocter@capsicure.com",[42,64,81,97,114,131,148],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"FOMAT Medical Research","RECRUITING","Oxnard","California","93030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-119.17705,34.1975,{"lat":54,"lon":53},[57,61],{"name":58,"role":38,"phone":59,"phoneExt":12,"email":60},"Luis Parra","805-483-1185","lparra@fomatmedical.com",{"name":62,"role":63,"phone":12,"phoneExt":12,"email":12},"David Blitzer, MD","PRINCIPAL_INVESTIGATOR",{"facility":65,"status":44,"city":66,"state":67,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Solutions Medical Research","Coral Gables","Florida","33134",{"type":51,"coordinates":70},[71,72],-80.26838,25.72149,{"lat":72,"lon":71},[75,79],{"name":76,"role":38,"phone":77,"phoneExt":12,"email":78},"Liliana Lorenzo","305-425-1238","liliana@solutionsmedicalresearch.com",{"name":80,"role":63,"phone":12,"phoneExt":12,"email":12},"Francisco Jose Oliva, DPM",{"facility":82,"status":44,"city":83,"state":67,"zip":84,"country":48,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Nova Medical Services - Research Division LLC","Miami","33176",{"type":51,"coordinates":86},[87,88],-80.19366,25.77427,{"lat":88,"lon":87},[91,95],{"name":92,"role":38,"phone":93,"phoneExt":12,"email":94},"Valmys Ortiz","786-715-9183","Valmys.Ortiz@novamedicalcare.com",{"name":96,"role":63,"phone":12,"phoneExt":12,"email":12},"Sandor Romero, MD",{"facility":98,"status":44,"city":99,"state":100,"zip":101,"country":48,"countryCode":49,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Indiana University Health Methodist Hospital","Indianapolis","Indiana","46202",{"type":51,"coordinates":103},[104,105],-86.15804,39.76838,{"lat":105,"lon":104},[108,112],{"name":109,"role":38,"phone":110,"phoneExt":12,"email":111},"Bryce Hockman","317-278-2715","bbhockma@iu.edu",{"name":113,"role":63,"phone":12,"phoneExt":12,"email":12},"Mithun Sinha, PhD",{"facility":115,"status":44,"city":116,"state":117,"zip":118,"country":48,"countryCode":49,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"St. Louis Foot and Ankle, LLC","St Louis","Missouri","63128",{"type":51,"coordinates":120},[121,122],-90.19789,38.62727,{"lat":122,"lon":121},[125,129],{"name":126,"role":38,"phone":127,"phoneExt":12,"email":128},"Bonnie Scaggs","314-596-9670","stlabdopodiatry@gmail.com",{"name":130,"role":63,"phone":12,"phoneExt":12,"email":12},"Raymond Abdo, DPM",{"facility":132,"status":44,"city":133,"state":134,"zip":135,"country":48,"countryCode":49,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Jevlos Health, Inc","Syosset","New York","11791",{"type":51,"coordinates":137},[138,139],-73.50207,40.82621,{"lat":139,"lon":138},[142,146],{"name":143,"role":38,"phone":144,"phoneExt":12,"email":145},"Christopher Infantino","516-816-8160","Christopher.Infantino@jevloshealth.org",{"name":147,"role":63,"phone":12,"phoneExt":12,"email":12},"Mamta Parikh, MD",{"facility":149,"status":44,"city":150,"state":151,"zip":152,"country":48,"countryCode":49,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Hope Vascular and Podiatry","Houston","Texas","77054",{"type":51,"coordinates":154},[155,156],-95.36327,29.76328,{"lat":156,"lon":155},[159,163],{"name":160,"role":38,"phone":161,"phoneExt":12,"email":162},"Mariana Burnier","346-541-6421","mburnier@hcic.io",{"name":164,"role":63,"phone":12,"phoneExt":12,"email":12},"Brian Lepow, DPM",{"type":166,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[168],{"name":169,"class":170},"BioLab Holdings","INDUSTRY","100596538","camp-rwe-trial-amnion-grafts-for-healing-hard-to-heal-ulcers-in-rw-populations-100596538",false,"NCT07046767","CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMP RWE","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. 2\\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2\n4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n5. Subject is able and willing to follow the protocol requirements\n6. 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 amniotic tissue grafts\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":182,"type":183},165,"ESTIMATED","INTERVENTIONAL",[186],"NA","CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[189,190,191],"Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer","Wound; Foot",[193,194,195,196],"DCF","VLU","Diabetic Foot Ulcer","Venus Leg Ulcer","2025-10-21",{"date":199,"type":200},"2025-10-22","ACTUAL",{"date":202,"type":200},"2025-10-01",{"date":204,"type":183},"2026-07-20",{"name":5,"class":6},7]