Study Stopped
decision to stop the study because of enrollment difficulties.
EVENT: Hydrotherapy and Deep Venous Thrombosis
Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.
1 other identifier
interventional
3
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Jul 2006
Shorter than P25 for phase_3 pain
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 4, 2006
CompletedFirst Posted
Study publicly available on registry
July 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedNovember 1, 2007
October 1, 2007
July 4, 2006
October 31, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence at 1 year of a severe post-thrombotic syndrome clinically defined.
1 year
Secondary Outcomes (7)
Post-thrombotic syndrome at 2 years;
2 years
Quality of life: CIVIQ Scale;
inclusion, 1, 2 years before and after thermal cure
Intensity of the symptoms of venous insufficiency auto evaluation by patient
monthly
Deep venous reflux (evaluated by echo-doppler);
inclusion, 1 and 2 years
Persistence of a residual thrombus (echo-doppler);
inclusion, 1 and 2 years
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORimmediate thermal cure (1st year)
2
SHAM COMPARATORlate thermal cure (2 years)
Interventions
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam
thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years
Eligibility Criteria
You may qualify if:
- both sexes;
- 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)
You may not qualify if:
- isolate distal thrombosis;
- asymptomatic thrombosis;
- cutaneous ulcer of lower limb;
- refusal to consent;
- refusal to benefit of thermal cure;
- contra-indication to hydrotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Etablissement thermal
Argelès-Gazost, 65400, France
Etablissement thermal
Bagnoles-de-l'Orne, 61140, France
Etablissement thermal
Barbotan-les-Thermes, 32150, France
L'avenue
Dax, 40100, France
Sarrailh
Dax, 40100, France
Le Splendid
Dax, 40101, France
Les thermes
Dax, 40101, France
Le miradour
Dax, 40103, France
Les arènes
Dax, 40103, France
Bérot
Dax, 40104, France
Les écureuils
Dax, 40104, France
Dax thermal
Dax, 40105, France
Foch
Dax, 40105, France
Borda
Dax, 40106, France
Saint-Pierre
Dax, 40106, France
Le Grand Hôtel
Dax, 40108, France
Le Regina
Dax, 40108, France
Etablissement thermal
Évian-les-Bains, 23110, France
Domaine d'heurteboise
Jonzac, 17503, France
Etablissement thermal
La Léchère, 73260, France
Etablissement thermal
Luxeuil-les-Bains, 70300, France
Etablissement thermal
Luz-Saint-Sauveur, 65120, France
Etablissement thermal
Rochefort, 17300, France
Caliceo
Saint-Paul-lès-Dax, 40990, France
Christus
Saint-Paul-lès-Dax, 40990, France
Chênes
Saint-Paul-lès-Dax, 40990, France
Etablissmeent thermal
Saubusse-les-bains, 40180, France
Related Publications (5)
Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.
PMID: 8644983BACKGROUNDKahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. doi: 10.1111/j.1538-7836.2005.01216.x. Epub 2005 Feb 23.
PMID: 15733061BACKGROUNDLabropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. doi: 10.1053/j.semvascsurg.2004.12.002.
PMID: 15791546BACKGROUNDAsbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82. doi: 10.7863/jum.2005.24.4.475.
PMID: 15784766BACKGROUNDLaunois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.
PMID: 8993100BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François POIRAULT, Dr
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 4, 2006
First Posted
July 6, 2006
Study Start
July 1, 2006
Study Completion
December 1, 2006
Last Updated
November 1, 2007
Record last verified: 2007-10