Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
Recruiting now · Not applicable
Conditions studied: Venous Insufficiency of Leg
In brief
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 facts
- Study ID
- NCT07362719
- Run by
- Société d'Exploitation des Thermes d'Amnéville
- People needed
- 84
- Starts
- 2026-02-27
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Centre Thermal Saint-Eloy — Amnéville, France (enrolling)
Full record on ClinicalTrials.gov
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