Phlebology-focused thermal cure for severe chronic venous insufficiency at Saint-Eloy Thermal Center.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Thermal Saint-Eloy
  Amnéville, France Recruiting

Study contacts

• Principal investigator: Claudine INVERNIZZI
• Study coordinator: Ophélie FLAGEUL
• Email: o.flageul@slbpharma.com
• Phone: +33 2 99 12 19 62

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.