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.
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 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.
Parallel
Phlebology oriented thermal cure
Other interventionThe 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.
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.
Efficacy in relieving symptoms of severe chronic venous insufficiency
Measurement of the evolution in the mVCSS (modified Venous Clinical Severity Score), as described in the primary outcome measure. The modified VCSS score consists of 9 items with a total score ranging from 0 to 27. It is rated for both legs.
Efficacy in relieving symptoms of severe chronic venous insufficiency
Measurement of the evolution in the complete VCSS (Venous Clinical Severity Score). The complete 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, Mild, Moderate, Severe) with a total VCSS score ranging from 0 to 30.
Pathology-related quality of life assessment
Self assessment of quality of life using the ChronIc Venous Insuficiency quality of life Questionnaire composed of 20 items (CIVIQ-20). The CIVIQ-20 is especially developped to assess the impact of chronic venous insufficiency on the patient's quality of life. A score will be calculated based on the questionnaire, from 20 to 100. The lower the score, the better the patient's quality of life.
Quality of life assessment
Self assessment of quality of life using the 5-dimension 5-level EuroQol (EQ-5D-5L) questionnaire, to assess the patient's general quality of life. The questionnaire consists of five questions (mobility, personal autonomy, daily activities, pain/discomfort, anxiety/depression) and a visual analog scale (VAS). For each patient, a health status (ranging from 11111 to 55555) will be obtained.
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Société d'Exploitation des Thermes d'Amnéville
Lead sponsor
Slb Pharma
Collaborator
