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

NCT07362719 | Recruiting

• 1 other identifier: AMNEVILLE-PHL
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Venous Insufficiency of Leg

Keywords

Severe chronic venous insufficiency; Thermal cure; Phlebology; Balneology; Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

• Efficacy in relieving symptoms of severe chronic venous insufficiency

  Measurement of the evolution in the modified Venous Clinical Severity Score (mVCSS ). The Venous Clinical Severity Score (VCSS) is composed of 10 items evaluating 8 clinical signs (pain, varicose veins, edema, skin pigmentation, inflammation, induration, ulcer, use of compression device). Each clinical sign is assessed on a scale of 0 to 3 (Absent (0), Mild (1), Moderate (2), Severe (3)) with a total VCSS score ranging from 0 to 30. The mVCSS excludes the item about the use of compression device because the thermal cure includes raising patient awareness about the importance of wearing compression devices. Thus, the modified VCSS score consists of 9 items with a total score ranging from 0 to 27. The lower the score, the fewer symptoms the patient has. The score is rated for both legs, but only the most severe leg based on the score at Baseline will be retained for the Primary Outcome Measure. The mVCSS is rated by an independant evaluator, and will be compared between both arms.

  At baseline, at 3 months

Secondary Outcomes (12)

• Efficacy in relieving symptoms of severe chronic venous insufficiency

  At baseline, at 3 months, at 6 months

• Efficacy in relieving symptoms of severe chronic venous insufficiency

  At baseline, at 3 months, at 6 months

• Pathology-related quality of life assessment

  At baseline, at 3 months, at 6 months

• Quality of life assessment

  At baseline, at 3 months, at 6 months

• Impact on patient discomfort

  At baseline, at 3 months, at 6 months

Study Arms (2)

Interventional (with phlebology-oriented thermal cure)

EXPERIMENTAL

Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center

Other: Phlebology oriented thermal cure

Control (no thermal cure)

NO INTERVENTION

Participants suffering from severe chronic venous insufficiency without thermal treatment.

Interventions

Phlebology oriented thermal cure OTHER

The phlebology oriented thermal cure takes place over a period of 3 consecutive weeks, with 6 days of cure per week (Monday to Saturday, i.e. 18 days). It includes 72 treatment sessions over the 18-day period and three medical consultations (including an initial consultation, a mid-course consultation, and a final consultation) organized by the resort's thermal doctors. The treatment program is established by the thermal doctor based on the patient's clinical profile.

Interventional (with phlebology-oriented thermal cure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Vulnerable persons (Art. L.1121-5 to 8, and L1122-1-2, French Public Health Code).

Sponsors & Collaborators

• Société d'Exploitation des Thermes d'Amnéville: lead
• Slb Pharma: collaborator

Study Sites (1)

Centre Thermal Saint-Eloy

Amnéville, 57360, France

RECRUITING

Study Officials

• Claudine INVERNIZZI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youna PERON

CONTACT

+33 2 99 12 19 62; y.peron@slbpharma.com

Guillaume DUMAS

CONTACT

+33 3 87 71 83 52; gdumas@polethermal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 23, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

FR (1)