Clinical trial NCT00838500: THERMES ET VEINES: Spa for Prevention of Leg Ulcers
Official title: Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Insufficiency
Leg Ulcer
Varicose Ulcer
Keywords: Venous insufficiency
Leg ulcer
balneology
hydrotherapy
Modified Rutherford score
Euroquol EQ 5d scale
CIVIQ2 scale
Visual analogic Scale
SPA treatment
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: Université Joseph Fourier
name: Floralis
First posted: 2009-02-06
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic venous insufficiency affects to differing extents half of the French population. The most advanced forms, with skin changes (CEAP clinical classes C4-5-6) affect 5% of the population and are those most often indicated for spa treatment. A venous condition is recognized as justifying spa therapy by 12 spa resorts in France. However, no specific or global benefit has been clearly scientifically shown for such therapy. One methodologically sound study (Carpentier 2009) demonstrated a benefit of spa therapy using a non-clinical intermediate endpoint (severity of skin changes). No study has shown efficacy of spa therapy in the primary and secondary prevention of the major and most common complication of advanced chronic venous insufficiency: leg ulcers.

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.

Eligibility criteria: Inclusion Criteria:

* Both sexes, more than 18 years old patients with a phlebological indication of spa treatment, with advanced chronic venous insufficiency, class C4a, or b or C5 of CEAP classification (leg ulcers must be healed since 3 months at least)
* 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:

* Pregnancy, parturient or breast feeding
* 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

Primary outcomes:
measure: Occurrence of a leg ulcer within the year following the inclusion. The ulcer will be classified C5 of CEAP (healed ulcer) or C6 (non healed ulcer)at the follow up visit.
timeFrame: 1 year
Secondary outcomes:
measure: Healing time of the leg ulcers within the first year
timeFrame: 12 months
measure: Quality of life: Euroqol EQ 5D, CIVIQ2 Scale
timeFrame: Inclusion - 6 months - 12 months- 18 months
measure: Aggravation level defined as at least 20% increase of the modified Rutherford score and mean comparison of this score at 1 year
timeFrame: Inclusion - 12 months - 18 months
measure: Visual analog scale for leg symptoms
timeFrame: Monthly (until 18 months)
measure: Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization)
timeFrame: Inclusion - 6, 12 and 18 months
Other outcomes:
Locations:
city: Albertville
country: France
facility: Cabinet médical
city: Angouleme
country: France
facility: Cabinet médical
city: Bagnoles de l'Orne
country: France
facility: Cabinet médical
city: Barbotan Les Thermes
country: France
facility: Cabinet médical
city: Bayonne
country: France
facility: Cabinet médical
city: Belfort
country: France
facility: Cabinet médical
city: DAX
country: France
facility: Hopital thermal
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Montlucon
country: France
facility: Cabinet médical
city: Montpellier
country: France
facility: Cabinet médical
city: PAU
country: France
facility: Cabinet médical
city: Rochefort
country: France
facility: Cabinet médical
city: Tarbes
country: France
facility: Cabinet médical
Study officials:
affiliation: Grenoble Hospital - France
name: Patrick PC CARPENTIER, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Ernst E, Saradeth T, Resch KL. A single blind randomized, controlled trial of hydrotherapy for varicose veins. Vasa. 1991;20(2):147-52.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.