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RECRUITING

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

Sponsor: Société d'Exploitation des Thermes d'Amnéville

View on ClinicalTrials.gov

Summary

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. Balneotherapy-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. The 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-27

Completion Date

2027-05

Last Updated

2026-03-02

Healthy Volunteers

Conditions

Venous Insufficiency of Leg

Interventions

OTHER

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.

Inclusion Criteria: * Adult male or female (≥ 18 years of age). * 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. * Patients with an indication for a thermal cure exclusively focused on phlebology. * 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. * Patients available to attend the visits scheduled in the protocol and able to complete the data collection documents. * For women of childbearing age: patient using effective contraception. * Patient affiliated with a health insurance plan or beneficiary (Art. L.1121-8-1, French Public Health Code). * Patient who has given their informed consent in writing regarding their participation in the protocol. Exclusion Criteria: * Patients with a contraindication to thermal cure. * Patients who have participated in thermal cure (regardless of type) within the last 9 months. * Patients who have had an ulcer on their lower limbs that has healed within the last 3 months. * 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. * Patients with an open ulcer on a lower limb (class C6). * Patients for whom interventional venous treatment is due to begin within the next 6 months. * Patients scheduled to undergo orthopedic surgery on the lower limbs within the next 6 months. * Patients who are unable to walk. * Patients with a known allergy to sulfur. * Patients with any medically significant findings or significant history that may impact safety, interpretation of results, and/or subject participation in the study at 6 months, in the investigator's opinion. * Patients simultaneously participating in another clinical trial or who have participated in another clinical trial for which the exclusion period has not ended. * Vulnerable persons (Art. L.1121-5 to 8, and L1122-1-2, French Public Health Code).

Locations (1)

Centre Thermal Saint-Eloy

Amnéville, France