[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585250":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":92,"collaborators":26,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":26,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Laboratoires URGO","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"light compression system","EXPERIMENTAL","Treatment with two bandages light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)",[13,14],"Device: Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)","Device: Light compression system of the mixed leg ulcer stage C6 \u002F C6r of the CEAP classification",{"label":16,"type":17,"description":18,"interventionNames":19},"tubular bandage","PLACEBO_COMPARATOR","Treatment with tubular bandage system during 16-week treament period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Treatment with light compression systeme during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)","Treatment with light compression system during 16-week treatment period (6 medical visits are planned: D0, W2, W4, W8, W12, W16)",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Light compression system of the mixed leg ulcer stage C6 \u002F C6r of the CEAP classification","Etiological treatment of mixed leg ulcer stage C6 \u002F C6r of the CEAP classification",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Patricia PaS SENET, Dr, MD, PhD","Hôpitaux Universitaires Paris Est (AP-HP) - Hôpital TENON","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Anne AnS SAUVADET, Dr, PhD","CONTACT","+33 6 71 19 78 91","+33 38044284","a.sauvadet@fr.urgo.com",{"name":44,"role":39,"phone":45,"phoneExt":26,"email":46},"Olivier OlT TACCA, Dr, PhD","+33 3 80 44 74 22","o.tacca@fr.urgo",[48,66,81],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Patricia SENET, Paris, Paris 75000","NOT_YET_RECRUITING","Paris","75000","France","FR",{"type":56,"coordinates":57},"Point",[58,59],2.3488,48.85341,{"lat":59,"lon":58},[62,64,65],{"name":38,"role":39,"phone":40,"phoneExt":63,"email":42},"+33 3 80442884",{"name":44,"role":39,"phone":45,"phoneExt":26,"email":46},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":67,"status":68,"city":69,"state":26,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Cabinet d'Angiologie - Médecine Vasculaire 377 rue Garibaldi 69007 LYON","RECRUITING","Lyon","69007",{"type":56,"coordinates":72},[73,74],4.84789,45.74906,{"lat":74,"lon":73},[77],{"name":78,"role":39,"phone":79,"phoneExt":26,"email":80},"Azeddine AzA ADDALA, MD","+33 4 78 72 38 98","a.addala@orange.fr",{"facility":82,"status":50,"city":51,"state":26,"zip":83,"country":53,"countryCode":54,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"APHP Hopital TENON Service de Dermatologie et médecine vasculaire 4 Rue de la Chine 75970 PARIS Cedex 20","75970",{"type":56,"coordinates":85},[58,59],{"lat":59,"lon":58},[88],{"name":89,"role":39,"phone":90,"phoneExt":26,"email":91},"Patricia PaS SENET, MD, PhD","+33 1 56 01 76 11","patricia.senet@aphp.fr",{"type":93,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100585250","efficacy-and-safety-of-light-compression-system-in-the-local-treatment-of-mixed-leg-ulcers-promethee-clinical-investigation-100585250",false,"NCT06899919","Efficacy and Safety of Light Compression System in the Local Treatment of Mixed Leg Ulcers (PROMETHEE Clinical Investigation)","Evaluation of the Efficacy and Safety of Light Compression System Versus Tubular Bandage in the Local Treatment of Mixed Leg Ulcers: a Prospective Open-label RCT","PROMETHEE","Inclusion Criteria:\n\n* Adult patient (≥ 18 years old), having given free, informed and written consent\n* Patient affiliated to a social security scheme\n* Patient agreeing to wear the study compression system daily\n* Patient with an ankle circumference between 18 and 25 cm\n* Target wound: stage C6 \u002F C6r mixed leg ulcer of the CEAP classification with a 0.6≤ ABPI≤0.8 and TABP≥ 50 mm Hg and arterial echo Doppler confirming the mixed nature of the leg ulcer\n* Target wound with an area between 2 and 20 cm2\n* Target wound with age of ≤18 months\n\nCriteria exclusion:\n\n* Patient with a systemic infection not controlled by appropriate antibiotic therapy\n* Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis\n* Severe arterial pathology, including an Ankle Blood Pressure Index (ABPI) less than 3 months old \\\u003C0.6\n* Patient bedridden or spending less than an hour per day standing\n* Clinically infected target wound\n* Cancerized target wound","ALL","18 Years",{"count":105,"type":106},210,"ESTIMATED","INTERVENTIONAL",[109],"NA","Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of a lite compression system versus a tubular bandage in the local treatment of mixed leg ulcers: prospective multicenter, randomized controlled, open-label french clinical study",[112],"Leg Ulcers",[114,115,9],"Mixed leg ulcers","Quality of life questionnaire","2025-04-07",{"date":118,"type":119},"2025-04-08","ACTUAL",{"date":121,"type":119},"2025-03-29",{"date":123,"type":106},"2027-09-30",{"name":5,"class":6},3]