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Can a stent heal leg ulcers that Won't close?

NCT ID NCT07762222

Disease control Sponsor: Ain Shams University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether placing a stent in a blocked pelvic vein can help heal chronic leg ulcers in people with post-thrombotic syndrome, a complication of deep vein thrombosis. Twenty adults with non-healing venous ulcers will receive the stenting procedure plus standard ulcer care and compression therapy. Researchers will track ulcer healing over 12 months, along with symptom scores and recurrence rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iliofemoral dedicated venous stenting (a procedure to open blocked veins in the pelvis and upper leg)
What this could lead to
If successful, this could offer a way to heal stubborn leg ulcers caused by post-thrombotic syndrome and improve quality of life.
What could go wrong
This is a small, early study with only 20 patients, so results may not apply broadly. The procedure carries risks like bleeding, infection, or stent problems.

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 20 people

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

Started

Mar 2025

Expected to finish

Jan 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 to 70 years

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: * Chronic non-healing venous ulcer associated with iliofemoral post-thrombotic syndrome. * CEAP clinical classification C6. * Iliofemoral post-thrombotic venous obstruction confirmed by appropriate venous imaging. * Age 18 years or older. * Ability to provide informed consent. Exclusion Criteria: * Nonthrombotic iliac vein lesion (NIVL). * Post-phlebitic femoropopliteal venous lesions with a patent iliac vein. * CEAP clinical classification other than C6. * Previous venous intervention. * Active pathological ulcer unrelated to post-thrombotic venous disease. * Life expectancy less than 2 years. * Pregnancy. * Known allergy to contrast media. * Contraindication to anesthesia. * Refusal to participate or inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

post-thrombotic syndrome Postthrombotic Syndrome ulcer of lower limbs Varicose Ulcer vascular disorder venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

DVT - deep vein thrombosis Post-thrombotic syndrome Vascular Venous ulcer of leg

How to take part

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

  1. The places running it

    1 site. 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

  • Ain shams univeristy hospital

    RECRUITING

    Cairo, 1181, Egypt

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