Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency (AMNEVILLE-PHL)

Société d'Exploitation des Thermes d'Amnéville

Status

Not yet enrolling

Conditions

Venous Insufficiency of Leg

Treatments

Other: Phlebology oriented thermal cure

Study type

Interventional

Funder types

Other

Identifiers

NCT07362719

AMNEVILLE-PHL

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).