THERMES ET VEINES: Spa for Prevention of Leg Ulcers

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838500
• Other study ID #: CUF 1497
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2009
• Last updated: September 28, 2012
• Start date: May 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: November 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency

Intervention

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...)
• 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...)

Locations

Country	Name	City	State
France	Cabinet médical	Albertville
France	Cabinet médical	Angouleme
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	Montlucon
France	Cabinet médical	Montpellier
France	Cabinet médical	PAU
France	Cabinet médical	Rochefort
France	Cabinet médical	Tarbes

Sponsors (3)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	Floralis, Université Joseph Fourier

Country where clinical trial is conducted

France, 

References & Publications (9)

Carpentier PH, Maricq HR, Biro C, Ponçot-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. — View 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. — View Citation

Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20. — View Citation

Eklöf 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. Review. — View Citation

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

Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Healing time of the leg ulcers within the first year		12 months	No
Secondary	Quality of life: Euroqol EQ 5D, CIVIQ2 Scale		Inclusion - 6 months - 12 months- 18 months	No
Secondary	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	No
Secondary	Visual analog scale for leg symptoms		Monthly (until 18 months)	No
Secondary	Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization)		Inclusion - 6, 12 and 18 months	No

External Links

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