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Stents for diabetic foot ulcers? trial pulled before it began

NCT ID NCT03404895

Disease control Sponsor: Windsor Ting Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study was designed to see if placing a stent in a blocked leg vein could help heal diabetic foot ulcers in people with diabetes and leg swelling. Patients would have received standard wound care plus either a stent or no stent. However, the trial was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
stent
What this could lead to
If it had worked, this could have pointed toward a new treatment to help heal diabetic foot ulcers and reduce amputations.
What could go wrong
The trial was withdrawn before any patients were enrolled, so no data exists. Even if conducted, stenting is not standard care and carries risks like infection or vein damage.

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.

Started

Apr 2018

Finished

Mar 2025

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

30 to 64 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: * Presence of diabetic foot ulcer within the foot (located distal to the ankle and proximal to base of toes) * Lower extremity edema * MRA or CTA showing stenosis of iliac vein or indirect findings that suggest presence of iliac vein stenosis (distal venous dilation and presence of collateral veins) * At least one palpable pedal pulse or ABI\>0.9 IVUS confirmation of iliac vein stenosis Exclusion Criteria: * Previous vein stent implantation involving study leg or inferior vena cava * Previous bypass surgery or endovascular intervention involving study leg * Known metal allergy * Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication * Acute deep venous thrombosis involving either leg * Known history of chronic occlusion of any vein in the study leg * Venous compression caused by tumor encasement * Venous outflow obstruction caused by tumor thrombus * Elevated baseline blood creatinine (\>1.5) * Pregnancy * Life expectancy \<12 months

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot Edema

As listed by the trial registrant

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

Diabetes Diabetic foot ulcer Edema

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

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