CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 425 enrolled
Drug / intervention
Immediate spa treatment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00838500
NCT00838500Phase 3Completed
CompareCT.gov

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

Association Francaise pour la Recherche Thermale·interventional·Posted Feb 6, 2009·Updated Oct 1, 2012

In Brief

A Phase 3 clinical trial evaluating Immediate spa treatment and Late spa treatment for Venous Insufficiency and 2 related conditions. Completed, enrolled 425 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Insufficiency, Leg Ulcer, Varicose Ulcer
CountriesFrance
CollaboratorsUniversité Joseph Fourier, Floralis

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2009
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2010
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.4 years ago

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...)