[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609183":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":134,"collaborators":136,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":25,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":25,"enrollmentInfo":151,"targetDuration":25,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"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",[42,58,67,75,83,91,102,113,123],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń","RECRUITING","Bialystok","15-879","Poland","PL",{"type":50,"coordinates":51},"Point",[52,53],23.16433,53.13333,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":25,"phoneExt":25,"email":25},"Nonna Nowak, MD, PhD",{"facility":59,"status":60,"city":61,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":25},"Centrum Medyczne Ultramed","WITHDRAWN","Krakow",{"type":50,"coordinates":63},[64,65],19.93658,50.06143,{"lat":65,"lon":64},{"facility":68,"status":60,"city":69,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":25},"MelissaMed Poradnia Chirurgiczna","Lodz",{"type":50,"coordinates":71},[72,73],19.47395,51.77058,{"lat":73,"lon":72},{"facility":76,"status":44,"city":69,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Mikomed Spółka Z Ograniczoną Odpowiedzialnością",{"type":50,"coordinates":78},[72,73],{"lat":73,"lon":72},[81],{"name":82,"role":38,"phone":25,"phoneExt":25,"email":25},"Jacek Mikosiński, MD",{"facility":84,"status":44,"city":69,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Niepubliczny Zakład Opieki Zdrowotnej \"Argo\" Centrum Medyczne",{"type":50,"coordinates":86},[72,73],{"lat":73,"lon":72},[89],{"name":90,"role":38,"phone":25,"phoneExt":25,"email":25},"Przemysław Lipiński, MD",{"facility":92,"status":44,"city":93,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"PP CLINIC Pietrzyk spółka partnerska lekarzy","Lublin",{"type":50,"coordinates":95},[96,97],22.57009,51.25058,{"lat":97,"lon":96},[100],{"name":101,"role":38,"phone":25,"phoneExt":25,"email":25},"Łukasz Pietrzyk, MD",{"facility":103,"status":44,"city":104,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota","Ostróda",{"type":50,"coordinates":106},[107,108],19.96486,53.69671,{"lat":108,"lon":107},[111],{"name":112,"role":38,"phone":25,"phoneExt":25,"email":25},"Katarzyna Rybołowicz, MD",{"facility":114,"status":44,"city":115,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Lecran - Centrum Opieki Nad Ranami-Kunickiego","Wroclaw",{"type":50,"coordinates":117},[118,119],17.03006,51.10286,{"lat":119,"lon":118},[122],{"name":32,"role":38,"phone":25,"phoneExt":25,"email":25},{"facility":124,"status":44,"city":125,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Specjalistyczna Pomoc Medyczna \"Medservice\"","Zabrze",{"type":50,"coordinates":127},[128,129],18.78576,50.32492,{"lat":129,"lon":128},[132],{"name":133,"role":38,"phone":25,"phoneExt":25,"email":25},"Wojciech Saucha, MD",{"type":135,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[137,140],{"name":138,"class":139},"Clean Data Labs","UNKNOWN",{"name":141,"class":139},"Sphera Clinical Research","100609183","suprasorbxphmb-pro-vs-suprasorbxphmb-in-treatment-of-infected-venous-leg-ulcers-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":152,"type":153},150,"ESTIMATED","INTERVENTIONAL",[156],"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.",[159],"Venous Leg Ulcer",[161,162,163,164],"maceration","bacterial cellulose dressing","PHMB","antimicrobial dressing","2026-03-26",{"date":167,"type":168},"2026-04-01","ACTUAL",{"date":170,"type":168},"2025-09-23",{"date":172,"type":153},"2027-06-15",{"name":5,"class":6},9]