[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620830":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":32,"locations":42,"responsibleParty":74,"collaborators":76,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":18,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"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],[25,28],{"name":26,"affiliation":18,"role":27},"Claudine INVERNIZZI","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":31},"Youna PERON","Slb Pharma","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Ophélie FLAGEUL","CONTACT","+33 2 99 12 19 62","o.flageul@slbpharma.com",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Guillaume DUMAS","+33 3 87 71 83 52","gdumas@polethermal.com",[43],{"facility":44,"status":45,"city":46,"state":18,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Centre Thermal Saint-Eloy","RECRUITING","Amnéville","57360","France","FR",{"type":51,"coordinates":52},"Point",[53,54],6.13414,49.25671,{"lat":54,"lon":53},[57,60,61,64,66,68,70,72],{"name":26,"role":35,"phone":58,"phoneExt":18,"email":59},"+33 3 87 70 99 43","contact_steloy@polethermal.com",{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":62,"role":63,"phone":18,"phoneExt":18,"email":18},"Judicaël BRAUNER BOYER","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":18,"phoneExt":18,"email":18},"Concetta GUYARD-INFANTINO",{"name":67,"role":63,"phone":18,"phoneExt":18,"email":18},"Jean-Jacques MARTINEC",{"name":69,"role":63,"phone":18,"phoneExt":18,"email":18},"Julie MATHIEU",{"name":71,"role":63,"phone":18,"phoneExt":18,"email":18},"Simon RUDYNSKI",{"name":73,"role":63,"phone":18,"phoneExt":18,"email":18},"Catherine DESMET",{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[77],{"name":30,"class":6},"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":88,"type":89},84,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95],"Venous Insufficiency of Leg",[97,98,99,100,95],"Severe chronic venous insufficiency","Thermal cure","Phlebology","Balneology","2026-07-17",{"date":103,"type":104},"2026-07-20","ACTUAL",{"date":106,"type":104},"2026-02-27",{"date":108,"type":89},"2027-05",{"name":5,"class":6},1]