[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609183":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":133,"collaborators":135,"id":141,"slug":25,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":25,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":25,"enrollmentInfo":149,"targetDuration":25,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Lohmann & Rauscher","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suprasorb®X+PHMB Pro","EXPERIMENTAL","Patients will receive the assigned wound dressing for 21 (±2) days, or till the complete epithelialization, if it occurs earlier. The patients should also receive adequate compression and, if necessary, systemic antimicrobial drug therapy.",[13],"Device: PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)",{"label":15,"type":16,"description":11,"interventionNames":17},"Suprasorb®X+PHMB","ACTIVE_COMPARATOR",[18],"Device: PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)","Application of a wound dressing with additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)","Application of a wound dressing without additional polyethylene film on top and compression therapy. Optional usage of the systemic antimicrobial therapy.",[15],[31],{"name":32,"affiliation":33,"role":34},"Konrad Pańczak, MD","LECRAN - CENTRUM OPIEKI NAD RANAMI-KUNICKIEGO","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Daria Trofimenko, MD","CONTACT","02631996385","daria.trofimenko@de.lrmed.com",[42,57,66,74,82,90,101,112,122],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń","RECRUITING","Bialystok","15-879","Poland",{"type":49,"coordinates":50},"Point",[51,52],23.16433,53.13333,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":25,"phoneExt":25,"email":25},"Nonna Nowak, MD, PhD",{"facility":58,"status":59,"city":60,"state":25,"zip":25,"country":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"Centrum Medyczne Ultramed","WITHDRAWN","Krakow",{"type":49,"coordinates":62},[63,64],19.93658,50.06143,{"lat":64,"lon":63},{"facility":67,"status":59,"city":68,"state":25,"zip":25,"country":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":25},"MelissaMed Poradnia Chirurgiczna","Lodz",{"type":49,"coordinates":70},[71,72],19.47395,51.77058,{"lat":72,"lon":71},{"facility":75,"status":44,"city":68,"state":25,"zip":25,"country":47,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Mikomed Spółka Z Ograniczoną Odpowiedzialnością",{"type":49,"coordinates":77},[71,72],{"lat":72,"lon":71},[80],{"name":81,"role":38,"phone":25,"phoneExt":25,"email":25},"Jacek Mikosiński, MD",{"facility":83,"status":44,"city":68,"state":25,"zip":25,"country":47,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Niepubliczny Zakład Opieki Zdrowotnej \"Argo\" Centrum Medyczne",{"type":49,"coordinates":85},[71,72],{"lat":72,"lon":71},[88],{"name":89,"role":38,"phone":25,"phoneExt":25,"email":25},"Przemysław Lipiński, MD",{"facility":91,"status":44,"city":92,"state":25,"zip":25,"country":47,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"PP CLINIC Pietrzyk spółka partnerska lekarzy","Lublin",{"type":49,"coordinates":94},[95,96],22.57009,51.25058,{"lat":96,"lon":95},[99],{"name":100,"role":38,"phone":25,"phoneExt":25,"email":25},"Łukasz Pietrzyk, MD",{"facility":102,"status":44,"city":103,"state":25,"zip":25,"country":47,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota","Ostróda",{"type":49,"coordinates":105},[106,107],19.96486,53.69671,{"lat":107,"lon":106},[110],{"name":111,"role":38,"phone":25,"phoneExt":25,"email":25},"Katarzyna Rybołowicz, MD",{"facility":113,"status":44,"city":114,"state":25,"zip":25,"country":47,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Lecran - Centrum Opieki Nad Ranami-Kunickiego","Wroclaw",{"type":49,"coordinates":116},[117,118],17.03006,51.10286,{"lat":118,"lon":117},[121],{"name":32,"role":38,"phone":25,"phoneExt":25,"email":25},{"facility":123,"status":44,"city":124,"state":25,"zip":25,"country":47,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Specjalistyczna Pomoc Medyczna \"Medservice\"","Zabrze",{"type":49,"coordinates":126},[127,128],18.78576,50.32492,{"lat":128,"lon":127},[131],{"name":132,"role":38,"phone":25,"phoneExt":25,"email":25},"Wojciech Saucha, MD",{"type":134,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[136,139],{"name":137,"class":138},"Clean Data Labs","UNKNOWN",{"name":140,"class":138},"Sphera Clinical Research","100609183",false,"NCT07211243","Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers","Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Infected\\* venous\\*\\* leg ulcer\n* Slightly to moderately exuding wound\\*\\*\\*\n* Patient has signed informed consent\n\n  * as per CDC definition, also TILI score ≥ 5 \\*\\* ABPI \\> 0.8 and \\\u003C 1.2 \\*\\*\\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases\n\nExclusion Criteria:\n\n* Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study\n* Wounds with exposed cartilage tissue (hyaline cartilage)\n* Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)\n* Known allergy and\u002For hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and \u002F or interpreta-tion of the study results.","ALL","18 Years",{"count":150,"type":151},150,"ESTIMATED","INTERVENTIONAL",[154],"NA","This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.",[157],"Venous Leg Ulcer",[159,160,161,162],"maceration","bacterial cellulose dressing","PHMB","antimicrobial dressing","2026-03-26",{"date":165,"type":166},"2026-04-01","ACTUAL",{"date":168,"type":166},"2025-09-23",{"date":170,"type":151},"2027-06-15",{"name":5,"class":6},9]