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Venous InsufficiencyPhase 3NCT00838500

THERMES ET VEINES: Spa for Prevention of Leg Ulcers

A Phase 3 study testing Immediate spa treatment and Late spa treatment in people with Venous Insufficiency and Leg Ulcer, run by Association Francaise pour la Recherche Thermale at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Insufficiency, Leg Ulcer, Varicose Ulcer
What is being tested?
Immediate spa treatment and Late spa treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
425 participants
Where
13 sitesFrance
Study dates
May 2008to Nov 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Cabinet médical

    Albertville, 73200

  • Cabinet médical

    Angoulême, 16000

  • Cabinet médical

    Bagnoles-de-l'Orne, 61140

  • Cabinet médical

    Barbotan-les-Thermes, 32150

  • Cabinet médical

    Bayonne, 64100

  • Cabinet médical

    Belfort, 90000

  • Hopital thermal

    Dax, 40100

  • University Hospital Grenoble

    Grenoble, 38043

  • Cabinet médical

    Montluçon, 03100

  • Cabinet médical

    Montpellier, 34000

  • Cabinet médical

    Pau, 64000

  • Cabinet médical

    Rochefort, 17300

  • Cabinet médical

    Tarbes, 65000

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Immediate spa treatment, Late spa treatment
Keywords
Venous insufficiency, Leg ulcer, balneology, hydrotherapy, Modified Rutherford score, Euroquol EQ 5d scale, CIVIQ2 scale, Visual analogic Scale, SPA treatment
Medical subject headings
Venous Insufficiency, Leg Ulcer, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate spa treatmentDrug

    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 treatmentDrug

    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...)

Study groups in NCT00838500
Study groupRoleWhat they receive
Immediate SPA treatmentActive comparatorImmediate spa treatment during 18 days soon after randomization (1 year)
Receives: Drug: Immediate spa treatment
Late SPA treatmentSham comparatorLate spa treatment during 18 days soon after 12 months visit (2nd year)
Receives: Drug: Late spa treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (5)

  1. Healing time of the leg ulcers within the first year

    Measured: 12 months

  2. Quality of life: Euroqol EQ 5D, CIVIQ2 Scale

    Measured: Inclusion - 6 months - 12 months- 18 months

  3. Aggravation level defined as at least 20% increase of the modified Rutherford score and mean comparison of this score at 1 year

    Measured: Inclusion - 12 months - 18 months

  4. Visual analog scale for leg symptoms

    Measured: Monthly (until 18 months)

  5. Evaluation of the costs involved by the venous insufficiency at 1 year (treatments, physical treatments, hospitalization)

    Measured: Inclusion - 6, 12 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2010
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00838500
Sponsor's protocol ID
CUF 1497
Status last verified
Sep 2012
First submitted
5 Feb 2009
Last updated
1 Oct 2012
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 15472591

  • 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.

    PubMed 18829219

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

    PubMed 1877335

  • 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.

    PubMed 15622385

  • 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.

    PubMed 10842165

  • 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.

    PubMed 8993100

  • 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.

    PubMed 7562765

  • 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.

    PubMed 15791546

  • 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.

    PubMed 15313740

  • 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.

    PubMed 24135621

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immediate spa treatment and Late spa treatment in people with Venous Insufficiency and Leg Ulcer, run by Association Francaise pour la Recherche Thermale at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00838500, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.

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