THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Venous Insufficiency Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency

• NCT number: NCT00838500
• Study type: Interventional
• Source: Association Francaise pour la Recherche Thermale
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Completion date: November 2011