[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":41,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Laboratoires URGO","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vashe solution","EXPERIMENTAL","Vashe solution is a wound irrigation solution that contain hypochlorous acid",[13],"Device: Vashe solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Saline solution","ACTIVE_COMPARATOR","Saline solution is an isotonic solution designed for irrigation purposes of wounds",[19],"Device: Saline solution",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","randomization to saline solution group for local management of venous or mixed leg ulcers",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"randomisation to Vashe solution group for local management of venous or mixed leg ulcers",[9],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Clémence TUMBA, PharmD","CONTACT","+33 3 80 44 74 09","0033 +","c.tumba@fr.urgo.com",{"name":37,"role":32,"phone":38,"phoneExt":39,"email":40},"Olivier TACCA, PhD","+33 3 80 44 74 22","0033+","o.tacca@fr.urgo.com",[42],{"facility":43,"status":25,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Comprehensive Wound Healing Center and Hyperbarics, Northwell Health","New York","11042","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":25,"phoneExt":25,"email":57},"Alisha OROPALLO, Principal Investigator, MD","Aoropallo@northwell.edu",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100626835","evaluation-of-the-efficacy-and-tolerance-of-vashe-solution-versus-saline-solution-in-the-treatment-of-venous-or-mixed-leg-ulcers-presenting-inflammatory-signs-suggesting-heavy-bacterial-load-100626835",false,"NCT07440797","EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD","EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD: MULTICENTER, PROSPECTIVE, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Adult patient, at least 18 years of age or older who has provided free, written, and informed consent,\n* Patient who has already worn compression therapy in the past and agrees to wear the two-layer compression system during the whole treatment period,\n* Patient presenting a venous or mixed leg ulcer predominantly of venous origin (ABPI between ≥0.8≤1.3,\n* Leg ulcer presenting at least 3 inflammatory signs (e.g pain, erythema...)\n* Target leg ulcer located at least 3 cm from the edge of another wound.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient,\n* Patient already participating in another clinical trial, except observational trial\n* Patient with epifascial arterial bypass (superficial arterial bypass)\n* Patient suffering from phlegmatia coerulea dolens, septic phlebitis, acute deep vein thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.\n* Patient receiving or having received systemic antibiotics within the ten days prior to inclusion in the investigation, regardless of therapeutic class or indication,\n* Cancerous wound.","ALL","18 Years",{"count":70,"type":71},102,"ESTIMATED","INTERVENTIONAL",[74],"NA","Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load",[77],"Venous Leg Ulcer (VLU)",[79,80,81],"venous leg ulcer","inflammatory signs","chronic wound","NOT_YET_RECRUITING","2026-03-02",{"date":85,"type":86},"2026-03-04","ACTUAL",{"date":88,"type":71},"2026-03",{"date":90,"type":71},"2027-03",{"name":5,"class":6},1]