THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer; Venous Insufficiency; Varicose Ulcer
• Intervention / Treatment: Drug: Immediate spa treatment; Drug: Late spa treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Albertville, France, 73200
    • Cabinet Médical
  • Angouleme, France, 16000
    • Cabinet Médical
  • Bagnoles de l'Orne, France, 61140
    • Cabinet Médical
  • Barbotan Les Thermes, France, 32150
    • Cabinet Médical
  • Bayonne, France, 64100
    • Cabinet Médical
  • Belfort, France, 90000
    • Cabinet Médical
  • DAX, France, 40100
    • Hopital thermal
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Montlucon, France, 03100
    • Cabinet Médical
  • Montpellier, France, 34000
    • Cabinet Médical
  • PAU, France, 64000
    • Cabinet Médical
  • Rochefort, France, 17300
    • Cabinet Médical
  • Tarbes, France, 65000
    • Cabinet Médical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Immediate SPA treatment; Immediate spa treatment during 18 days soon after randomization (1 year)	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...)
SHAM_COMPARATOR: Late SPA treatment; Late spa treatment during 18 days soon after 12 months visit (2nd year)	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...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Healing time of the leg ulcers within the first year	12 months
Quality of life: Euroqol EQ 5D, CIVIQ2 Scale	Inclusion - 6 months - 12 months- 18 months
Aggravation level defined as at least 20% increase of the modified Rutherford score and mean comparison of this score at 1 year	Inclusion - 12 months - 18 months
Visual analog scale for leg symptoms	Monthly (until 18 months)
Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization)	Inclusion - 6, 12 and 18 months

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale
• Collaborators: Université Joseph Fourier; Floralis
• Investigators: Principal Investigator: Patrick PC CARPENTIER, Professor, Grenoble Hospital - France

Publications and helpful links

General Publications

• 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.

Helpful Links

• e_crf test website (username: THERMES99 - Passwor:thermestst)

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (ESTIMATE): February 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Venous insufficiency; SPA treatment; Leg ulcer; hydrotherapy; Euroquol EQ 5d scale; balneology; Modified Rutherford score; CIVIQ2 scale; Visual analogic Scale
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: CUF 1497