[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620830":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":70,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":18,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Société d'Exploitation des Thermes d'Amnéville","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional (with phlebology-oriented thermal cure)","EXPERIMENTAL","Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center",[13],"Other: Phlebology oriented thermal cure",{"label":15,"type":16,"description":17,"interventionNames":18},"Control (no thermal cure)","NO_INTERVENTION","Participants suffering from severe chronic venous insufficiency without thermal treatment.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Phlebology oriented thermal cure","The phlebology oriented thermal cure takes place over a period of 3 consecutive weeks, with 6 days of cure per week (Monday to Saturday, i.e. 18 days). It includes 72 treatment sessions over the 18-day period and three medical consultations (including an initial consultation, a mid-course consultation, and a final consultation) organized by the resort's thermal doctors. The treatment program is established by the thermal doctor based on the patient's clinical profile.",[9],[25],{"name":26,"affiliation":18,"role":27},"Claudine INVERNIZZI","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Youna PERON","CONTACT","+33 2 99 12 19 62","y.peron@slbpharma.com",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Guillaume DUMAS","+33 3 87 71 83 52","gdumas@polethermal.com",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre Thermal Saint-Eloy","RECRUITING","Amnéville","57360","France","FR",{"type":47,"coordinates":48},"Point",[49,50],6.13414,49.25671,{"lat":50,"lon":49},[53,56,57,60,62,64,66,68],{"name":26,"role":31,"phone":54,"phoneExt":18,"email":55},"+33 3 87 70 99 43","contact_steloy@polethermal.com",{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":58,"role":59,"phone":18,"phoneExt":18,"email":18},"Judicaël BRAUNER BOYER","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":18,"phoneExt":18,"email":18},"Concetta GUYARD-INFANTINO",{"name":63,"role":59,"phone":18,"phoneExt":18,"email":18},"Jean-Jacques MARTINEC",{"name":65,"role":59,"phone":18,"phoneExt":18,"email":18},"Julie MATHIEU",{"name":67,"role":59,"phone":18,"phoneExt":18,"email":18},"Simon RUDYNSKI",{"name":69,"role":59,"phone":18,"phoneExt":18,"email":18},"Catherine DESMET",{"type":71,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[73],{"name":74,"class":6},"Slb Pharma","100620830","therapeutic-efficacy-of-the-phlebology-oriented-thermal-cure-at-the-saint-eloy-thermal-center-in-the-treatment-of-symptoms-of-severe-chronic-venous-insufficiency-100620830",false,"NCT07362719","Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency","AMNEVILLE-PHL","Inclusion Criteria:\n\n* Adult male or female (≥ 18 years of age).\n* Patients with severe chronic venous insufficiency of the lower limbs (C4a,b,c - C5 according to the CEAP (Clinical manifestations, Etiology, Anatomic distibution, Pathophysiology) classification (2020 revision) for at least one of the legs) confirmed by venous Doppler ultrasound of the lower limbs.\n* Patients with an indication for a thermal cure exclusively focused on phlebology.\n* Patients available to participate in a 3-week consecutive thermal cure at the Saint-Eloy Thermal Center, followed by 6 months of clinical follow-up, in accordance with the protocol schedule.\n* Patients available to attend the visits scheduled in the protocol and able to complete the data collection documents.\n* For women of childbearing age: patient using effective contraception.\n* Patient affiliated with a health insurance plan or beneficiary (Art. L.1121-8-1, French Public Health Code).\n* Patient who has given their informed consent in writing regarding their participation in the protocol.\n\nExclusion Criteria:\n\n* Patients with a contraindication to thermal cure.\n* Patients who have participated in thermal cure (regardless of type) within the last 9 months.\n* Patients who have had an ulcer on their lower limbs that has healed within the last 3 months.\n* Patients without venous trophic disorders of the lower limbs, and in particular patients with isolated class C3 chronic venous insufficiency or less in both lower limbs.\n* Patients with an open ulcer on a lower limb (class C6).\n* Patients for whom interventional venous treatment is due to begin within the next 6 months.\n* Patients scheduled to undergo orthopedic surgery on the lower limbs within the next 6 months.\n* Patients who are unable to walk.\n* Patients with a known allergy to sulfur.\n* Patients with any medically significant findings or significant history that may impact safety, interpretation of results, and\u002For subject participation in the study at 6 months, in the investigator's opinion.\n* Patients simultaneously participating in another clinical trial or who have participated in another clinical trial for which the exclusion period has not ended.\n* Vulnerable persons (Art. L.1121-5 to 8, and L1122-1-2, French Public Health Code).","ALL","18 Years",{"count":85,"type":86},84,"ESTIMATED","INTERVENTIONAL",[89],"NA","Chronic venous insufficiency (CVI) is a common progressive vascular disease that affects nearly one-third of the French population. Despite considerable advances in the treatment of chronic venous insufficiency, this condition remains a burden for patients and national healthcare systems.\n\nBalneotherapy-which includes thermal cures-is part of the therapeutic arsenal used in the treatment of chronic venous insufficiency. It is a relatively effective alternative with a relatively low cost compared to drug or surgical treatments. Phlebology is a thermal treatment orientation recognized by the French social security system.\n\nThe Saint-Eloy Thermal Center is listed among the thermal stations approved by the French Ministry of Health. It currently uses thermal water from Amnéville-les-Thermes to treat rheumatological and respiratory conditions, and wants to expand its range of orientations by adding phlebology. The AMNEVILLE-PHL study therefore aims to evaluate the efficacy and safety of the Saint-Eloy thermal cure for phlebology in patients suffering from severe chronic venous insufficiency.",[92],"Venous Insufficiency of Leg",[94,95,96,97,92],"Severe chronic venous insufficiency","Thermal cure","Phlebology","Balneology","2026-02-27",{"date":100,"type":101},"2026-03-02","ACTUAL",{"date":98,"type":101},{"date":104,"type":86},"2027-05",{"name":5,"class":6},1]