Status:
RECRUITING
Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
Lead Sponsor:
Société d'Exploitation des Thermes d'Amnéville
Collaborating Sponsors:
Slb Pharma
Conditions:
Venous Insufficiency of Leg
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ins...
Eligibility 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).
Key Trial Info
Start Date :
February 27 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07362719
Start Date
February 27 2026
End Date
May 1 2027
Last Update
March 2 2026
Active Locations (1)
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1
Centre Thermal Saint-Eloy
Amnéville, France, 57360