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New study aims to set better standards for treating severe leg artery disease

NCT ID NCT04710563

Knowledge-focused Sponsor: Yale University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is collecting information from 458 people with critical limb-threatening ischemia, a severe form of peripheral artery disease that can lead to amputation. The goal is to learn how different treatments affect patients' daily lives and health outcomes. Researchers hope to use this knowledge to create better guidelines for diagnosing and treating this condition.

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

458 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Sep 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

Patients will be enrolled from a range of clinical practices combining forces from vascular surgery, vascular medicine (interventional) cardiology, wound care specialists and podiatry clinics that treat CLI patients. All patients will be medically stable, i.e., not actively experiencing a life-threatening critical condition for which emergent care processes are ongoing, before they are approached for inclusion in the study.

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. All race/ethnicity categories, English speaking, men and women 2. Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6 3. Age ≥18 years 4. Supported by any of the following diagnostic evidence: * Rutherford Classification 4 or ischemic rest pain and/or resting ankle pressure \<50mmHg, flat or barely pulsatile ankle or metatarsal PVR or toe pressure \<40mmHg * Rutherford Classification 5 or minor tissue loss; non-healing ulcer, focal gangrene with diffuse pedal ischemia resting ankle pressure \<50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure \<40mmHg * Rutherford Classification 6 or major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable, resting ankle pressure \<50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure \<40mmHg * CLI related ICD 10 code (reason for admission or indication for procedure) * SPP \< 50 mmHg * TCPO2 \< 50 mmHg * Angiographic evidence no straight line to foot or greater than 70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal) * ABI\* ≤ 0.90 * non-compressible ABI ≥ 1.40 AND TBI ≤ 0.70 * TBI\* ≤ 0.70 Exclusion Criteria: 1. Acute limb ischemia 2. Unable to provide written informed consent 3. Currently a prisoner (identified at time of enrollment)

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Conditions

The condition(s) this trial relates to.

limb ischemia peripheral arterial disease

As listed by the trial registrant

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

Peripheral arterial disease

Contacts and locations

Locations

  • Yale New Haven Health

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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