THERMES ET VEINES: Spa for Prevention of Leg Ulcers (NCT00838500) | Clinical Trial Compass
CompletedPhase 3
THERMES ET VEINES: Spa for Prevention of Leg Ulcers
France425 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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.
Timeframe: 1 year
Trial details
NCT IDNCT00838500
SponsorAssociation Francaise pour la Recherche Thermale