Phlebology-focused thermal cure for severe chronic venous insufficiency at Saint-Eloy Thermal Center.
Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
This will test whether a three-week phlebology-focused thermal cure at Saint-Eloy helps adults with severe chronic venous insufficiency of the legs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Société d'Exploitation des Thermes d'Amnéville Academic / other |
| Locations | 1 site (Amnéville) |
| Trial ID | NCT07362719 on ClinicalTrials.gov |
What this trial studies
This interventional program offers a three-week consecutive phlebology-oriented thermal cure using the Amnéville-les-Thermes waters at the Saint-Eloy Thermal Center, followed by six months of clinical follow-up. Eligible adults have severe chronic venous insufficiency (CEAP C4a,b,c or C5) confirmed by venous Doppler and an indication for a phlebology-focused thermal cure. The protocol collects clinical safety and symptom outcomes over the immediate treatment period and during scheduled follow-up visits. The approach builds on balneotherapy practice as a lower-cost, noninvasive option alongside existing medical and surgical care.
Who should consider this trial
Good fit: Adults (≥18) with severe lower-limb chronic venous insufficiency (CEAP C4a,b,c or C5) confirmed by Doppler who can undertake a three-week consecutive thermal cure at Saint-Eloy and attend six months of follow-up are ideal candidates.
Not a fit: People without severe CVI, those unable to commit to a three-week stay or follow-up visits, or those with contraindications to thermal therapies are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this treatment could reduce leg symptoms and skin complications from severe chronic venous insufficiency and offer a lower-cost noninvasive option.
How similar studies have performed: Previous balneotherapy research has shown modest symptomatic benefits for venous disease, but phlebology-oriented thermal cures have limited rigorous randomized trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Amnéville
- Centre Thermal Saint-Eloy — Amnéville, France (Recruiting)
Study contacts
- Principal investigator: Claudine INVERNIZZI
- Study coordinator: Youna PERON
- Email: y.peron@slbpharma.com
- Phone: +33 2 99 12 19 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.