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

Обзор

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.

Вмешательства

• Другое Phlebology oriented thermal cure
  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.

Первичные конечные точки

• Efficacy in relieving symptoms of severe chronic venous insufficiency [Срок оценки: At baseline, at 3 months]

Вторичные конечные точки (12)

• Efficacy in relieving symptoms of severe chronic venous insufficiency [Срок оценки: At baseline, at 3 months, at 6 months]
• Efficacy in relieving symptoms of severe chronic venous insufficiency [Срок оценки: At baseline, at 3 months, at 6 months]
• Pathology-related quality of life assessment [Срок оценки: At baseline, at 3 months, at 6 months]
• Quality of life assessment [Срок оценки: At baseline, at 3 months, at 6 months]
• Impact on patient discomfort [Срок оценки: At baseline, at 3 months, at 6 months]
• Impact on skin pigmentation [Срок оценки: At baseline, at 3 months, at 6 months]
• Safety of Thermal Cure [Срок оценки: Through study completion, an average of 6 months]
• Impact of the thermal cure focused on the the patient's clinical evolution assessed by the investigator [Срок оценки: At 3 months, at 6 months]
• Impact of the thermal cure focused on the the patient's clinical evolution self-assessed by the patient [Срок оценки: At 3 months, at 6 months]
• Compliance for wearing compression devices [Срок оценки: At baseline, at 3 months, at 6 months]
• Patient satisfaction with the Saint-Eloy phlebology-oriented thermal cure [Срок оценки: Between 3 weeks and 2 months]
• Medico-economic impact [Срок оценки: At baseline, at 3 months, at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Centre Thermal Saint-Eloy — Amnéville

Идентификаторы

NCT: NCT07362719 · AMNEVILLE-PHL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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