[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419147":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":44,"overallOfficials":54,"centralContacts":66,"locations":72,"responsibleParty":131,"collaborators":134,"id":136,"slug":23,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":23,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":23,"enrollmentInfo":144,"targetDuration":23,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":74,"whyStopped":23,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Time to ulcer Healing","Complete re-epithelialisation of ulcer area","0-365 days",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"EQ-5D Questionnaire","Score 0-100 where higher is better",{"measure":18,"description":19,"timeFrame":12},"Wound-QOL Questionnaire","Score 0-17 where lower is better",{"measure":21,"description":22,"timeFrame":12},"Venous ulcer area","Reduction on venous ulcer maximum diameter",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.\n\nIn addition to the first-visit treatment in the study group, both groups receive endothermal ablation and\u002For foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).\n\nClass 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.\n\nFor this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.\n\nAssuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).",[32,39],{"label":33,"type":34,"description":35,"interventionNames":36},"First-visit foam sclerotherapy","EXPERIMENTAL","Patients in the first-visit foam sclerotherapy group undergo first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy), and truncal vein endothermal ablation is scheduled when the anatomy is suitable. Compression therapy is initiated immediately.",[37,38],"Procedure: Endothermal Ablation","Procedure: Foam Sclerotherapy",{"label":40,"type":41,"description":42,"interventionNames":43},"Scheduled treatment","ACTIVE_COMPARATOR","Patients in the scheduled treatment group receive scheduled endovenous ablation, including foam sclerotherapy and\u002For endothermal ablation, depending on reflux anatomy. This group represents the current standard of care. Compression therapy is initiated immediately.",[37,38],[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":23},"PROCEDURE","Endothermal Ablation","Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and\u002For Small Saphenous Vein)",[33,40],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"Foam Sclerotherapy","Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.",[33,40],[55,58,61,64],{"name":56,"affiliation":5,"role":57},"Toni Pihlaja, MD","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":60,"role":57},"Karoliina Halmesmaki, Docent","Helsinki University Central Hospital",{"name":62,"affiliation":60,"role":63},"Maarit Venermo, Professor","STUDY_CHAIR",{"name":65,"affiliation":5,"role":63},"Matti Pokela, Docent",[67],{"name":65,"role":68,"phone":69,"phoneExt":70,"email":71},"CONTACT","083152011","+315","matti.pokela@ppshp.fi",[73,87,98,107,119],{"facility":60,"status":74,"city":75,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Helsinki","Finland","FI",{"type":79,"coordinates":80},"Point",[81,82],24.93545,60.16952,{"lat":82,"lon":81},[85],{"name":59,"role":68,"phone":23,"phoneExt":23,"email":86},"karoliina.halmesmaki@hus.fi",{"facility":88,"status":74,"city":89,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Keski-Suomen keskussairaala","Jyväskylä",{"type":79,"coordinates":91},[92,93],25.72088,62.24147,{"lat":93,"lon":92},[96],{"name":97,"role":68,"phone":23,"phoneExt":23,"email":23},"Tiia Kukkonen",{"facility":5,"status":74,"city":99,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Oulu",{"type":79,"coordinates":101},[102,103],25.46816,65.01236,{"lat":103,"lon":102},[106],{"name":65,"role":68,"phone":23,"phoneExt":23,"email":71},{"facility":108,"status":74,"city":109,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Turku University Hospital","Turku",{"type":79,"coordinates":111},[112,113],22.26869,60.45148,{"lat":113,"lon":112},[116],{"name":117,"role":68,"phone":23,"phoneExt":23,"email":118},"Harri Hakovirta, Professor","harri.hakovirta@tyks.fi",{"facility":120,"status":74,"city":121,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Vaasa Central Hospital","Vaasa",{"type":79,"coordinates":123},[124,125],21.61577,63.096,{"lat":125,"lon":124},[128],{"name":129,"role":68,"phone":23,"phoneExt":23,"email":130},"Vesa Rajala, MD","vesa.rajala@vshp.fi",{"type":57,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Toni Pihlaja","Principal Investigator",[135],{"name":60,"class":6},"100419147",false,"NCT04737941","Finnish Venous Ulcer Study (FINNULCER Study)","Finnish Venous Ulcer Study","Inclusion Criteria:\n\n* Patient informed consent\n* Venous ulcer, aged from one month to one year\n* Duplex ultrasonography verified (vein reflux greater than \\>0.5 second) superficial venous insufficiency\n* Sufficient arterial circulation (at least on criterion met: Palpable distal pulses \u002F ankle-brachial index \\> 0,8 \u002F Toe pressure \\>60mmhg)\n\nExclusion Criteria:\n\n* Leg ulcers other than venous etiology\n* Ulcers requiring operation theater revision\n* Patent foramen ovale\n* Several times recurrent (over 3 recurrences) venous ulcer\n* Body Mass Index over 40\n* Pregnancy","ALL","18 Years",{"count":145,"type":146},248,"ESTIMATED","INTERVENTIONAL",[149],"NA","This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.",[152],"Venous Leg Ulcer",[152,51,47,154],"Sub-ulcer Foam Sclerotherapy","2025-01-13",{"date":157,"type":158},"2025-01-15","ACTUAL",{"date":160,"type":158},"2021-02-26",{"date":162,"type":146},"2026-03-01",{"name":5,"class":6},5]