[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484479":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":106,"collaborators":20,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":20,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":20,"enrollmentInfo":117,"targetDuration":20,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":131,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Molnlycke Health Care AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive Care with Mepilex Up","EXPERIMENTAL","All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.",[13],"Device: Mepilex Up",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Mepilex Up","Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal.\n\nMepilex Up consists of:\n\n* a soft silicone wound contact layer (Safetac)\n* a flexible absorbent pad of compressed polyurethane foam\n* an outer polyurethane film which is breathable but waterproof\n\nDressing material content:\n\nSilicone, polyurethane",[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",[37,59,73,89],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Center for Clinical Research, Inc.","RECRUITING","Castro Valley","California","94546","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.08635,37.6941,{"lat":49,"lon":48},[52,57],{"name":53,"role":29,"phone":54,"phoneExt":55,"email":56},"Gayana Sarkisova, CCRC","800-363-1069","104","gayana@ccr-trials.com",{"name":58,"role":25,"phone":20,"phoneExt":20,"email":20},"Alexander Reyzelman, DPM",{"facility":60,"status":39,"city":61,"state":41,"zip":62,"country":43,"countryCode":44,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Felix Sigal, DPM","Los Angeles","90010",{"type":46,"coordinates":64},[65,66],-118.24368,34.05223,{"lat":66,"lon":65},[69,72],{"name":70,"role":29,"phone":20,"phoneExt":20,"email":71},"Maira Jackson, MA","maira@lafootpain.com",{"name":60,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":24,"status":39,"city":74,"state":75,"zip":76,"country":43,"countryCode":44,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Miami","Florida","33125",{"type":46,"coordinates":78},[79,80],-80.19366,25.77427,{"lat":80,"lon":79},[83,87],{"name":84,"role":29,"phone":85,"phoneExt":20,"email":86},"Aliette Espinosa","305-689-3376","a.espinosa2@med.miami.edu",{"name":88,"role":25,"phone":20,"phoneExt":20,"email":20},"Hadar Lev-Tov, MD",{"facility":90,"status":39,"city":91,"state":92,"zip":93,"country":43,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Serena Group Research Institute","Pittsburgh","Pennsylvania","15222",{"type":46,"coordinates":95},[96,97],-79.99589,40.44062,{"lat":97,"lon":96},[100,104],{"name":101,"role":29,"phone":102,"phoneExt":20,"email":103},"Laura Serena","412-335-0764","lserena@serenagroups.com",{"name":105,"role":25,"phone":20,"phoneExt":20,"email":20},"Thomas Serena, MD",{"type":107,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100484479","a-clinical-investigation-to-follow-the-progress-of-exuding-chronic-wounds-using-mepilex-up-as-the-primary-dressing-100484479",false,"NCT05588583","A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.","A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up","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 or DFU\n* Exudate amount moderate to large\n* Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician\n* For VLU: 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* For VLU: 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* Patients participating in the DIPLO NBF study\n* Use of wound fillers","ALL","18 Years",{"count":118,"type":119},68,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. 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 Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.",[125,126,127,128,129,130],"Wounds","Wound of Skin","Wound Leg","Wound; Foot","Diabetic Foot Ulcer","Venous Leg Ulcer",[129,130],"2023-04-18",{"date":134,"type":135},"2023-04-20","ACTUAL",{"date":137,"type":135},"2022-10-31",{"date":139,"type":119},"2024-03",{"name":5,"class":6},4]