Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
425 participants
INTERVENTIONAL
2008-05-31
2011-11-30
Brief Summary
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Detailed Description
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Vascular hemodynamics and in particular venous return from the lower limbs is subject to the laws of physics. Thus, the roles of the calf muscle venous pump and hydrostatic pressure in venous insufficiency rationalizes the use of balneotherapy techniques in the management of this pathology.
The spa therapy techniques used in the context of venous insufficiency have well-defined physiopathic targets and the hemodynamic and microcirculatory effects of some of them have been demonstrated. The high degree of satisfaction of patients taking the waters annually for venous conditions indirectly testifies to their enhanced well-being. Among venous indications, the prevention of post-thrombotic syndrome is one of the best recognized by the medical profession.Nevertheless, there has been no real validation of this indication with an acceptable methodology that meets the canons of evidence based medicine.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immediate SPA treatment
Immediate spa treatment during 18 days soon after randomization (1 year)
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...)
Late SPA treatment
Late spa treatment during 18 days soon after 12 months visit (2nd year)
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...)
Interventions
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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...)
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...)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Université Joseph Fourier
OTHER
Floralis
INDUSTRY
Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Principal Investigators
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Patrick PC CARPENTIER, Professor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital - France
Locations
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Cabinet médical
Albertville, , France
Cabinet médical
Angoulême, , France
Cabinet médical
Bagnoles-de-l'Orne, , France
Cabinet médical
Barbotan-les-Thermes, , France
Cabinet médical
Bayonne, , France
Cabinet médical
Belfort, , France
Hopital thermal
Dax, , France
University Hospital Grenoble
Grenoble, , France
Cabinet médical
Montluçon, , France
Cabinet médical
Montpellier, , France
Cabinet médical
Pau, , France
Cabinet médical
Rochefort, , France
Cabinet médical
Tarbes, , France
Countries
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References
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Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004 Oct;40(4):650-9. doi: 10.1016/j.jvs.2004.07.025.
Carpentier PH, Satger B. Randomized trial of balneotherapy associated with patient education in patients with advanced chronic venous insufficiency. J Vasc Surg. 2009 Jan;49(1):163-70. doi: 10.1016/j.jvs.2008.07.075. Epub 2008 Oct 1.
Ernst E, Saradeth T, Resch KL. A single blind randomized, controlled trial of hydrotherapy for varicose veins. Vasa. 1991;20(2):147-52.
Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.
Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.
Launois 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.
Constant F, Collin JF, Guillemin F, Boulange M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.
Labropoulos 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.
Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56. doi: 10.7326/0003-4819-141-4-200408170-00004.
Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.
Related Links
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e\_crf test website (username: THERMES99 - Passwor:thermestst)
Other Identifiers
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CUF 1497
Identifier Type: -
Identifier Source: org_study_id