THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Association Francaise pour la Recherche Thermale425 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

425

Conditions

Venous Insufficiency Leg Ulcer Varicose Ulcer

Interventions

Immediate spa treatmentDRUG

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...)

Late spa treatmentDRUG

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...)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Cabinet médical

Albertville, France

Cabinet médical

Angoulême, France

Cabinet médical

Bagnoles-de-l'Orne, France

Cabinet médical

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Healing time of the leg ulcers within the first year

Time frame: 12 months

Quality of life: Euroqol EQ 5D, CIVIQ2 Scale

Time frame: 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

Time frame: Inclusion - 12 months - 18 months

Visual analog scale for leg symptoms

Time frame: Monthly (until 18 months)

Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization)

Time frame: Inclusion - 6, 12 and 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.