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PainPhase 3NCT00348907

EVENT: Hydrotherapy and Deep Venous Thrombosis

A Phase 3 study testing thermal cure and late thermal cure in people with Pain and Deep Venous Thrombosis, run by Association Francaise pour la Recherche Thermale at 27 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Deep Venous Thrombosis
What is being tested?
thermal cure and late thermal cure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
27 sitesFrance
Study dates
Jul 2006to Dec 2006
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;
  • 18 years old and more;
  • clinical indication of thermal cure (first phase of deep venous thrombosis authenticated by unilateral venous echo-doppler
  • curative anticoagulant treatment more than 3 month;
  • oedema and/or spontaneous pain with functional discomfort;
  • available for a thermal cure during 18 days and a follow-up period of 36 month;
Show all 9Show fewer
  • voluntary to participate to the study, informed consent form signed after appropriate information;
  • affiliation to the social security system or equivalent;
  • no previous participation to a thermal cure (in the indication of phlebology)

Who cannot join

  • isolate distal thrombosis;
  • asymptomatic thrombosis;
  • cutaneous ulcer of lower limb;
  • refusal to consent;
  • refusal to benefit of thermal cure;
  • contra-indication to hydrotherapy.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

France27 sites

  • Etablissement thermal

    Argelès-Gazost, 65400

  • Etablissement thermal

    Bagnoles-de-l'Orne, 61140

  • Etablissement thermal

    Barbotan-les-Thermes, 32150

  • L'avenue

    Dax, 40100

  • Sarrailh

    Dax, 40100

  • Le Splendid

    Dax, 40101

  • Les thermes

    Dax, 40101

  • Le miradour

    Dax, 40103

  • Les arènes

    Dax, 40103

  • Bérot

    Dax, 40104

  • Les écureuils

    Dax, 40104

  • Dax thermal

    Dax, 40105

  • Foch

    Dax, 40105

  • Borda

    Dax, 40106

  • Saint-Pierre

    Dax, 40106

  • Le Grand Hôtel

    Dax, 40108

  • Le Regina

    Dax, 40108

  • Etablissement thermal

    Évian-les-Bains, 23110

  • Domaine d'heurteboise

    Jonzac, 17503

  • Etablissement thermal

    La Léchère, 73260

  • Etablissement thermal

    Luxeuil-les-Bains, 70300

  • Etablissement thermal

    Luz-Saint-Sauveur, 65120

  • Etablissement thermal

    Rochefort, 17300

  • Caliceo

    Saint-Paul-lès-Dax, 40990

  • Christus

    Saint-Paul-lès-Dax, 40990

  • Chênes

    Saint-Paul-lès-Dax, 40990

  • Etablissmeent thermal

    Saubusse-les-bains, 40180

Other trials in France

About this study

Official title: Evaluation of the Efficacy of the Thermal Cure in the Prevention of the Post-Thrombotic Syndrome After a Deep Venous Thrombosis of Lower Limbs.

The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

Read the detailed description

Venous thrombo-embolic disease (VTED) is a frequent pathology. The incidence is about 5 to 20 cases for 10000 persons each year, in a general population. The immediate risk is the pulmonary embolism potentially fatal. So, it justifies all the works in clinical research during the last years. Those studies allow many progresses, diagnostic and therapeutic, for the immediate undertaking of the patients. Despite that, VTED is a major problem of public health and the diminution of the mortality lied to VTED is one of the objectives of the French law relative to the politics of Public Health (August 2004). At more long-term, the post-thrombotic syndrome lead to an incapacitating pathology, which requires many cares. The frequency of the post-thrombotic syndrome is evaluated between 25 and 60% at middle-term (1 or 2 years). It depends of the studies and of the clinical primary end-points or vascular explorations. Rehabilitation has never been validated in this indication by studies with a correct methodology.

Deep venous thrombosis (not in acute phase) is recognized as an indication for about 10 spa in France. But the specific or global benefit of this water cure is not clearly and scientifically proved. The importance of the venous pump of the calf and of the hydrostatic pressure in the physiopathology of the post-thrombotic syndrome make natural the use of balneotherapy for the prevention of this pathology for patients with severe deep venous thrombosis of lower limbs (proximal and obstruent). The venous thermal techniques have well-defined physiopathological targets. The haemodynamic and microcirculatory effects of some of them have been proved. The high degree of satisfaction of the patients that benefit from phlebological water cure every year in France indirectly shows the benefits that they feel. In those indications, prevention of the post-thrombotic syndrome is one of the well-recognize by the medical profession. For all that, there was not really validation of this indication with an acceptable methodology for the canons of the modern medicine. That is the reason why we undertake this randomized, single-blind controlled study with for main objective to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

Being tested
thermal cure, late thermal cure
Keywords
doppler, CIVIQ quality of life, Hydrotherapy, anticoagulants
Medical subject headings
Pain, Venous Thrombosis

What participants receive

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

  • thermal cureDrug

    thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam

  • late thermal cureDrug

    thermal cure of 18 days including movement in swimming pool, mud-bath, shower, massage and thermal steam at 2 years

Study groups in NCT00348907
Study groupRoleWhat they receive
1Active comparatorimmediate thermal cure (1st year)
Receives: Drug: thermal cure
2Sham comparatorlate thermal cure (2 years)
Receives: Drug: late thermal cure

What is being measured

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

  1. Presence at 1 year of a severe post-thrombotic syndrome clinically defined.

    Measured: 1 year

Secondary outcomes (7)

  1. Post-thrombotic syndrome at 2 years;

    Measured: 2 years

  2. Quality of life: CIVIQ Scale;

    Measured: inclusion, 1, 2 years before and after thermal cure

  3. Intensity of the symptoms of venous insufficiency auto evaluation by patient

    Measured: monthly

  4. Deep venous reflux (evaluated by echo-doppler);

    Measured: inclusion, 1 and 2 years

  5. Persistence of a residual thrombus (echo-doppler);

    Measured: inclusion, 1 and 2 years

  6. Correlation between clinical evolution and echo-doppler evolution of the venous after-effects;

    Measured: 1 year

  7. Benefit of a late cure at 2 years.

    Measured: 2 years

Timeline

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

  1. First posted6 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Study completionDec 2006

Why it stopped: decision to stop the study because of enrollment difficulties.

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348907
Sponsor's protocol ID
DCIC 05 45
Status last verified
Oct 2007
First submitted
4 Jul 2006
Last updated
1 Nov 2007
Results posted
No
Data monitoring committee
No

Publications

  • Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.

    PubMed 8644983

  • Kahn SR, Kearon C, Julian JA, Mackinnon B, Kovacs MJ, Wells P, Crowther MA, Anderson DR, Van Nguyen P, Demers C, Solymoss S, Kassis J, Geerts W, Rodger M, Hambleton J, Ginsberg JS; Extended Low-intensity Anticoagulation for Thrombo-embolism (ELATE) Investigators. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost. 2005 Apr;3(4):718-23. doi: 10.1111/j.1538-7836.2005.01216.x. Epub 2005 Feb 23.

    PubMed 15733061

  • 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

  • Asbeutah AM, Riha AZ, Cameron JD, McGrath BP. Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med. 2005 Apr;24(4):475-82. doi: 10.7863/jum.2005.24.4.475.

    PubMed 15784766

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing thermal cure and late thermal cure in people with Pain and Deep Venous Thrombosis, run by Association Francaise pour la Recherche Thermale at 27 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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 was stopped early (reason given: decision to stop the study because of enrollment difficulties.). Results are not available in the source record.

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?

Presence at 1 year of a severe post-thrombotic syndrome clinically defined. (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 NCT00348907, which also lists 5 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 Nov 2007.

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