THERMES ET VEINES: Spa for Prevention of Leg Ulcers

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association Francaise pour la Recherche Thermale
• Collaborators: Floralis; Université Joseph Fourier

Criteria

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