Status:
COMPLETED
THERMES ET VEINES: Spa for Prevention of Leg Ulcers
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Collaborating Sponsors:
Université Joseph Fourier
Floralis
Conditions:
Venous Insufficiency
Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00838500
Start Date
May 1 2008
End Date
November 1 2011
Last Update
October 1 2012
Active Locations (13)
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1
Cabinet médical
Albertville, France, 73200
2
Cabinet médical
Angoulême, France, 16000
3
Cabinet médical
Bagnoles-de-l'Orne, France, 61140
4
Cabinet médical
Barbotan-les-Thermes, France, 32150