THERMES ET VEINES: Spa for Prevention of Leg Ulcers

This study has been completed.
Sponsor:
Collaborators:
Université Joseph Fourier
Floralis Subsidiary Company
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT00838500
First received: February 5, 2009
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Venous Insufficiency
Leg Ulcer
Varicose Ulcer
Drug: Immediate spa treatment
Drug: Late spa treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Healing time of the leg ulcers within the first year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life: Euroqol EQ 5D, CIVIQ2 Scale [ Time Frame: Inclusion - 6 months - 12 months- 18 months ] [ Designated as safety issue: No ]
  • Aggravation level defined as at least 20% increase of the modified Rutherford score and mean comparison of this score at 1 year [ Time Frame: Inclusion - 12 months - 18 months ] [ Designated as safety issue: No ]
  • Visual analog scale for leg symptoms [ Time Frame: Monthly (until 18 months) ] [ Designated as safety issue: No ]
  • Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization) [ Time Frame: Inclusion - 6, 12 and 18 months ] [ Designated as safety issue: No ]

Enrollment: 425
Study Start Date: May 2008
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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...)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838500

Locations
France
Cabinet médical
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
Hopital thermal
DAX, France, 40100
University Hospital Grenoble
Grenoble, France, 38043
Cabinet médical
Montlucon, France, 03100
Cabinet médical
Montpellier, France, 34000
Cabinet médical
PAU, France, 64000
Cabinet médical
Rochefort, France, 17300
Cabinet médical
Tarbes, France, 65000
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Université Joseph Fourier
Floralis Subsidiary Company
Investigators
Principal Investigator: Patrick PC CARPENTIER, Professor Grenoble Hospital - France
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT00838500     History of Changes
Other Study ID Numbers: CUF 1497
Study First Received: February 5, 2009
Last Updated: September 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by Association Francaise pour la Recherche Thermale:
Venous insufficiency
Leg ulcer
balneology
hydrotherapy
Modified Rutherford score
Euroquol EQ 5d scale
CIVIQ2 scale
Visual analogic Scale
SPA treatment

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Venous Insufficiency
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014