THERMES ET VEINES: Spa for Prevention of Leg Ulcers

NCT00838500 | Completed Phase 3 DMC

• 1 other identifier: CUF 1497
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Immediate SPA treatment

ACTIVE COMPARATOR

Immediate spa treatment during 18 days soon after randomization (1 year)

Drug: Immediate spa treatment

Late SPA treatment

SHAM COMPARATOR

Late spa treatment during 18 days soon after 12 months visit (2nd year)

Drug: Late spa treatment

Interventions

Immediate spa treatment DRUG

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...)

Immediate SPA treatment

Late spa treatment DRUG

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...)

Late SPA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Université Joseph Fourier: collaborator
• Floralis: collaborator

Study Sites (13)

Cabinet médical

Albertville, 73200, France

Location

Cabinet médical

Angoulême, 16000, France

Location

Cabinet médical

Bagnoles-de-l'Orne, 61140, France

Location

Cabinet médical

Barbotan-les-Thermes, 32150, France

Location

Cabinet médical

Bayonne, 64100, France

Location

Cabinet médical

Belfort, 90000, France

Location

Hopital thermal

Dax, 40100, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

Cabinet médical

Montluçon, 03100, France

Location

Cabinet médical

Montpellier, 34000, France

Location

Cabinet médical

Pau, 64000, France

Location

Cabinet médical

Rochefort, 17300, France

Location

Cabinet médical

Tarbes, 65000, France

Location

Related Publications (10)

• 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.

  PMID: 15472591 BACKGROUND

• 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.

  PMID: 18829219 BACKGROUND

• Ernst E, Saradeth T, Resch KL. A single blind randomized, controlled trial of hydrotherapy for varicose veins. Vasa. 1991;20(2):147-52.

  PMID: 1877335 BACKGROUND

• 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.

  PMID: 15622385 BACKGROUND

• 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.

  PMID: 10842165 BACKGROUND

• 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.

  PMID: 8993100 BACKGROUND

• 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.

  PMID: 7562765 BACKGROUND

• 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.

  PMID: 15791546 BACKGROUND

• 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.

  PMID: 15313740 BACKGROUND

• 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.

  PMID: 24135621 DERIVED

Related Links

• e\_crf test website (username: THERMES99 - Passwor:thermestst)

MeSH Terms

Conditions

Venous Insufficiency; Leg Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins

Study Officials

• Patrick PC CARPENTIER, Professor

  Grenoble Hospital - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2011
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

FR (13)