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Ultrasound clot size may predict chronic leg pain after DVT

NCT ID NCT06385353

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study looks at 400 people with a first-time deep vein thrombosis (DVT) in the leg. Researchers want to see if the amount of clot seen on an ultrasound can predict who will develop post-thrombotic syndrome (PTS), a condition causing long-term leg pain, swelling, and skin changes. By identifying high-risk patients early, doctors hope to prevent or reduce the severity of PTS.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Patients with symptomatic acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus (patients with stable pulmonary embolism associated with a symptomatic deep venous thrombosis can be included) 3. Affiliates or beneficiaries of a social security scheme. Exclusion Criteria: 1. Pregnant women, women in labour or breastfeeding mothers. 2. Pulmonary embolism haemodynamically unstable defined by systolic blood pressure \< 90 mmHg or a drop in systolic blood pressure of at least 40 mmHg during at least 15 min, shock or cardiac arrest. 3. Asymptomatic venous thrombosis. 4. Symptomatic venous thrombosis of both lower limbs (patients with bilateral deep venous thrombosis but symptomatic on one side only can be included). 5. History of ipsilateral or contralateral venous thrombosis of the lower limb. 6. Fracture or orthopedic surgery of the lower limbs in the last 3 months. 7. Dependance caused by age or secondary to a chronic affection, going from the inability to stand up or walk alone without help to bed or armchair rest over. 8. Prophylactic or therapeutic anticoagulant treatment \> 5 days. 9. Expected duration of anticoagulant treatment \< 3 months (all patients must have a minimum treatment of 3 months). 10. Patient estimated at high risk of bleeding according to investigator clinical judgment (renal, platelet, digestive, hepatic, neurological... origin) . 11. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery). 12. Refusal or inability to give written informed consent to participate in the study. 13. Life expectancy \< 6 months. 14. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice. 15. Patients taking part in a research project for venous thromboembolism that can interfere with the conduct of DVT-BURDEN research.

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Conditions

The condition(s) this trial relates to.

post-thrombotic syndrome Postthrombotic Syndrome Venous Thrombosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postthrombotic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH de Vichy

    RECRUITING

    Vichy, Allier, 03200, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

  • CHU de Besançon

    RECRUITING

    Besançon, Doubs, 25030, France

  • CHU de Dijon

    RECRUITING

    Dijon, Côte d'Or, 21000, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, Haute-Garonne, 31400, France

  • Cabinet libéral

    TERMINATED

    Martigues, Bouches-du-Rhône, 13500, France

  • Cabinet libéral

    RECRUITING

    Ajaccio, Corse-du-sud, 20090, France

  • Cabinet libéral

    RECRUITING

    Ajaccio, Corse-du-sud, 20090, France

  • Cabinet libéral

    RECRUITING

    Sanary-sur-Mer, Var, 83110, France

  • Cabinet libéral

    RECRUITING

    Six-Fours-les-Plages, Var, 83140, France

  • Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer

    RECRUITING

    Toulon, Var, 830054, France

  • Centre Hospitalier Universitaire Amiens Picardie

    RECRUITING

    Amiens, Somme, 830054, France

  • Centre Hospitalier Universitaire de Brest

    RECRUITING

    Brest, Finistère, 29069, France

  • Centre Hospitalier Universitaire de Nantes

    RECRUITING

    Nantes, 44000, France

  • Centre Hospitalier d'Avignon

    RECRUITING

    Avignon, Vaucluse, 84000, France

  • Centre Hospitalier de Carcassonne

    RECRUITING

    Carcassonne, Aude, 11010, France

  • Centre Hospitalier de Fréjus/Saint-Raphaël

    TERMINATED

    Fréjus, Var, 83600, France

  • Centre cardio-vasculaire Esterel

    WITHDRAWN

    Saint-Raphaël, Var, 83700, France

  • Centre de Santé Polyvalent de UGESSAP

    TERMINATED

    Montoir-de-Bretagne, Loire-Atlantique, 44550, France

  • Clinique Rive Gauche

    RECRUITING

    Toulouse, Haut-Garonne, 31076, France

  • Hospices Civils de Lyon, Hôpital Edouard Herriot

    RECRUITING

    Lyon, Rhône, 69003, France

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • Hôpital La Timone, AP-HM

    RECRUITING

    Marseille, Bouches-du-Rhône, 13385, France

  • Hôpital Saint Joseph

    RECRUITING

    Marseille, Bouches-du-Rhône, 13008, France

  • Hôpital Saint Joseph

    RECRUITING

    Paris, 75014, France

  • Hôpital d'Aubagne

    NOT_YET_RECRUITING

    Aubagne, Bouches-du-Rhône, 13400, France

  • Polyclinique Les Fleurs

    RECRUITING

    Ollioules, Var, 83190, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.