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THERMES ET VEINES: Spa for Prevention of Leg Ulcers

NCT00838500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2012-10-01

No results posted yet for this study

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.

Conditions

  • Venous Insufficiency
  • Leg Ulcer
  • Varicose Ulcer

Interventions

DRUG

Immediate spa treatment

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...)

DRUG

Late spa treatment

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...)

Sponsors & Collaborators

  • Université Joseph Fourier

    collaborator OTHER

  • Floralis

    collaborator INDUSTRY

  • Association Francaise pour la Recherche Thermale

    lead OTHER

Principal Investigators

  • Patrick PC CARPENTIER, Professor · Grenoble Hospital - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-12-31
Completion
2011-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838500 on ClinicalTrials.gov