Therapeutic Efficacy of the Phlebology-oriented Thermal Cure at the Saint-Eloy Thermal Center in the Treatment of Symptoms of Severe Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Efficacy in relieving symptoms of severe chronic venous insufficiency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Interventional (with phlebology-oriented thermal cure)
Participants suffering from severe chronic venous insufficiency receiving thermal treatment at the Saint-Eloy Thermal Center
干预措施: Phlebology oriented thermal cure (Other)
Control (no thermal cure)
Participants suffering from severe chronic venous insufficiency without thermal treatment.
结局指标
主要结局
Efficacy in relieving symptoms of severe chronic venous insufficiency
时间窗: At baseline, at 3 months
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.
次要结局
- 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)
- Impact on skin pigmentation(At baseline, at 3 months, at 6 months)
- Safety of Thermal Cure(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(At 3 months, at 6 months)
- Impact of the thermal cure focused on the the patient's clinical evolution self-assessed by the patient(At 3 months, at 6 months)
- Compliance for wearing compression devices(At baseline, at 3 months, at 6 months)
- Patient satisfaction with the Saint-Eloy phlebology-oriented thermal cure(Between 3 weeks and 2 months)
- Medico-economic impact(At baseline, at 3 months, at 6 months)