Status:
TERMINATED
EVENT: Hydrotherapy and Deep Venous Thrombosis
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Conditions:
Pain
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.
Detailed Description
Venous thrombo-embolic disease (VTED) is a frequent pathology. The incidence is about 5 to 20 cases for 10000 persons each year, in a general population. The immediate risk is the pulmonary embolism p...
Eligibility Criteria
Inclusion
- both sexes;
- 18 years old and more;
- clinical indication of thermal cure (first phase of deep venous thrombosis authenticated by unilateral venous echo-doppler
- curative anticoagulant treatment more than 3 month;
- oedema and/or spontaneous pain with functional discomfort;
- available for a thermal cure during 18 days and a follow-up period of 36 month;
- voluntary to participate to the study, informed consent form signed after appropriate information;
- affiliation to the social security system or equivalent;
- no previous participation to a thermal cure (in the indication of phlebology)
Exclusion
- isolate distal thrombosis;
- asymptomatic thrombosis;
- cutaneous ulcer of lower limb;
- refusal to consent;
- refusal to benefit of thermal cure;
- contra-indication to hydrotherapy.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00348907
Start Date
July 1 2006
End Date
December 1 2006
Last Update
November 1 2007
Active Locations (27)
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1
Etablissement thermal
Argelès-Gazost, France, 65400
2
Etablissement thermal
Bagnoles-de-l'Orne, France, 61140
3
Etablissement thermal
Barbotan-les-Thermes, France, 32150
4
L'avenue
Dax, France, 40100