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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Page 1 of 1 (1 locations)

1

Centre Thermal Saint-Eloy

Amnéville, France, 57360

Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency | DecenTrialz