[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485995":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":93,"collaborators":20,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":20,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":20,"enrollmentInfo":104,"targetDuration":20,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Molnlycke Health Care AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive Care with Non-Bordered Foam Dressing","EXPERIMENTAL","All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.",[13],"Device: ALLEVYN Non-Adhesive",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ALLEVYN Non-Adhesive","ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction.\n\nALLEVYN Non-Adhesive consists of the following layers:\n\n* Breathable top film\n* Highly absorbent foam core\n* Non-adhesive wound contact layer",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Hadar Lev-Tov, MD, MAS","University of Miami","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Janet Kandrevas, MD, MS","CONTACT","734-358-2174","janet.kandrevas@molnlycke.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Andrea Picchietti, MS, CCRA","260-258-3879","andrea.picchietti@molnlycke.com",[37,59,76],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Center for Clinical Trials, Inc.","NOT_YET_RECRUITING","San Francisco","California","94115","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.41942,37.77493,{"lat":49,"lon":48},[52,57],{"name":53,"role":29,"phone":54,"phoneExt":55,"email":56},"Gayana Sarkisova, CCRC","800-363-1063","104","gayana@ccr-trials.com",{"name":58,"role":25,"phone":20,"phoneExt":20,"email":20},"Alexander Reyzelman, DPO",{"facility":24,"status":60,"city":61,"state":62,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"RECRUITING","Miami","Florida","33125",{"type":46,"coordinates":65},[66,67],-80.19366,25.77427,{"lat":67,"lon":66},[70,74],{"name":71,"role":29,"phone":72,"phoneExt":20,"email":73},"Aliette Espinosa","305-689-3376","a.espinosa2@med.miami.edu",{"name":75,"role":25,"phone":20,"phoneExt":20,"email":20},"Hadar Lev-Tov, MD",{"facility":77,"status":60,"city":78,"state":79,"zip":80,"country":43,"countryCode":44,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Serena Group Research Institute","Pittsburgh","Pennsylvania","15222",{"type":46,"coordinates":82},[83,84],-79.99589,40.44062,{"lat":84,"lon":83},[87,91],{"name":88,"role":29,"phone":89,"phoneExt":20,"email":90},"Laura Serena","412-335-0764","lserena@serenagroups.com",{"name":92,"role":25,"phone":20,"phoneExt":20,"email":20},"Thomas Serena, MD",{"type":94,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100485995","a-clinical-investigation-to-follow-the-progress-of-exuding-chronic-venous-leg-ulcers-using-a-non-bordered-foam-dressing-100485995",false,"NCT05608317","A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing","A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing","Inclusion Criteria:\n\n* Signed consent to participate (including consent for digital imaging)\n* Adult aged ≥18 years\n* Diagnosed with a chronic, exuding VLU\n* Exudate amount moderate to large\n* Wound size from 3 cm2 to 30 cm2, as determined by the clinician\n* ABPI (within 3 months) \\> 0.7. If ABPI \\> 1.4, then big toe pressure \\> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow\n* Willing to be compliant with compression therapy\n\nExclusion Criteria:\n\n* Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment\n* Circumferential wound\n* Known allergy\u002Fhypersensitivity to the materials of the dressing\n* Use of wound fillers","ALL","18 Years",{"count":105,"type":106},20,"ESTIMATED","INTERVENTIONAL",[109],"NA","The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.\n\nParticipants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.",[112,113,114,115],"Wounds","Wound of Skin","Wound Leg","Venous Leg Ulcer",[115],"2024-05-03",{"date":119,"type":120},"2024-05-06","ACTUAL",{"date":122,"type":120},"2022-11-08",{"date":124,"type":106},"2024-11-30",{"name":5,"class":6},3]