THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Study Overview
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Brief Summary
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The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous insufficiency (C4a-b and C5 of the CEAP classification) at one year.

Detailed Description
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Chronic venous insufficiency affects to differing extents half of the French population. The most advanced forms, with skin changes (CEAP clinical classes C4-5-6) affect 5% of the population and are those most often indicated for spa treatment. A venous condition is recognized as justifying spa therapy by 12 spa resorts in France. However, no specific or global benefit has been clearly scientifically shown for such therapy. One methodologically sound study (Carpentier 2009) demonstrated a benefit of spa therapy using a non-clinical intermediate endpoint (severity of skin changes). No study has shown efficacy of spa therapy in the primary and secondary prevention of the major and most common complication of advanced chronic venous insufficiency: leg ulcers. Vascular hemodynamics and in particular venous return from the lower limbs is subject to the laws of physics. Thus, the roles of the calf muscle venous pump and hydrostatic pressure in venous insufficiency rationalizes the use of balneotherapy techniques in the management of this pathology. The spa therapy techniques used in the context of venous insufficiency have well-defined physiopathic targets and the hemodynamic and microcirculatory effects of some of them have been demonstrated. The high degree of satisfaction of patients taking the waters annually for venous conditions indirectly testifies to their enhanced well-being. Among venous indications, the prevention of post-thrombotic syndrome is one of the best recognized by the medical profession.Nevertheless, there has been no real validation of this indication with an acceptable methodology that meets the canons of evidence based medicine.

Official Title
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Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.

Conditions
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Venous Insufficiency, Leg Ulcer, Varicose Ulcer

Intervention / Treatment
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* Drug: Immediate spa treatment
* Drug: Late spa treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes, more than 18 years old patients with a phlebological indication of spa treatment, with advanced chronic venous insufficiency, class C4a, or b or C5 of CEAP classification (leg ulcers must be healed since 3 months at least) Available for a spa treatment during 18 days (immediate or late spa)and a follow-up period of 18 months Voluntary to participate to the study,informed consent form signed after appropriate information Affiliation to the social security system or equivalent Exclusion Criteria: Pregnancy, parturient or breast feeding No psychiatric illness or social situation that would preclude study compliance Leg ulcer in progress Leg ulcer healed for less than 3 months Refusal to consent Refusal of spa treatment Contra-indication of spa treatment(cancer in progress, psychiatric disorders, immunodeficiency) Arteriopathy of lower limb with an Ankle Brachial Pressure Index (ABPI)< 0.7, symptomatic neuropathy, erysipelas within 5 years prior to inclusion Surgical or endovascular treatment of the venous disease planned during the first year or during the six months prior to inclusion No previous phlebological spa treatment within 6 months prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate SPA treatment<br>Immediate spa treatment during 18 days soon after randomization (1 year) | Drug: Immediate spa treatment<br>* 1st year, soon after randomization: Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts(walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower...)<br>|
| Sham Comparator: Late SPA treatment<br>Late spa treatment during 18 days soon after 12 months visit (2nd year) | Drug: Late spa treatment<br>* 2nd year, soon after 12 months visit: Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts(walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower...)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a leg ulcer within the year following the inclusion. The ulcer will be classified C5 of CEAP (healed ulcer) or C6 (non healed ulcer)at the follow up visit. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time of the leg ulcers within the first year |  | 12 months | 
| Quality of life: Euroqol EQ 5D, CIVIQ2 Scale |  | Inclusion - 6 months - 12 months- 18 months | 
| Aggravation level defined as at least 20% increase of the modified Rutherford score and mean comparison of this score at 1 year |  | Inclusion - 12 months - 18 months | 
| Visual analog scale for leg symptoms |  | Monthly (until 18 months) | 
| Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization) |  | Inclusion - 6, 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous insufficiency, Leg ulcer, balneology, hydrotherapy, Modified Rutherford score, Euroquol EQ 5d scale, CIVIQ2 scale, Visual analogic Scale, SPA treatment