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Desperate measure: rerouting veins to save legs from amputation

NCT ID NCT06277362

Disease control Sponsor: EndoCore Lab s.r.l. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a procedure that connects an artery to a vein in the foot to bring blood to tissues when standard treatments have failed. It includes 50 patients with severe leg artery disease and active wounds. The goal is to see if the procedure is safe and can prevent major amputation.

What this could mean

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

Active substance
percutaneous deep foot venous arterialization procedure
What this could lead to
If it works, this could provide a way to save limbs and avoid amputation in patients with severe leg artery disease who cannot have standard treatments.
What could go wrong
This is an early study with only 50 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or failure to restore blood flow.

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.

Participants

About 50 people

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

Started

Jan 2020

Expected to finish

Dec 2028

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.

Who is studied

Subjects presenting the most advanced stage of lower limb arterial disease, defined as patients with CLTI and no indication for revascularization.

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: * Age ≥18 years * Patient has signed an approved informed consent form * All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage. * Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions * Ejection Fraction \> 30% Exclusion Criteria: * Subject no able to perform the follow up or other factors making clinical follow-up difficult * Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4) * Ejection Fraction \< 30%

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Conditions

The condition(s) this trial relates to.

Diabetic Foot limb ischemia peripheral arterial disease

As listed by the trial registrant

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

Critical limb-threatening ischemia Diabetic foot Peripheral arterial disease

How to take part

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

  1. The places running it

    7 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

  • Arcispedale Santa Maria Nuova

    WITHDRAWN

    Reggio Emilia, Italy, 42122, Italy

  • Azienda Ospedaliera S. Maria della Misericordia

    NOT_YET_RECRUITING

    Perugia, Perugia, 06156, Italy

  • Irccs Inrca

    RECRUITING

    Ancona, Ancona, 60129, Italy

  • Ospedale Bufalini

    RECRUITING

    Cesena, Italy, 47521, Italy

  • Ospedale Cardarelli

    RECRUITING

    Naples, Italy, 80131, Italy

  • Ospedale Pederzoli

    RECRUITING

    Peschiera del Garda, Veneto, 37019, Italy

  • Ospedale San Martino

    RECRUITING

    Belluno, Italy, 32100, Italy

  • Ospedale Santa Chiara

    RECRUITING

    Trento, Italy, 38123, Italy

  • Ospedale di Conegliano - USLL2

    WITHDRAWN

    Conegliano, Italy, 31015, Italy

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