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Veterans' PAD study pulled before it began

NCT ID NCT05648630

Knowledge-focused Sponsor: VA Office of Research and Development 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to see if a plant-based supplement called PB125 could help veterans with peripheral artery disease (PAD) get more benefit from exercise. The idea was that PB125 might reduce inflammation and oxidative stress, making it easier for patients to walk and exercise. However, the study was withdrawn before enrolling any participants, so no results are available.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
PB125 (a plant-based supplement)

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

Jul 2023

Finished

Oct 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index \< 0.9) * Must understand the study requirements and be willing and able to sign an informed consent document * Patients with mild cognitive impairment (i.e., montreal cognitive assessment (MOCA) \<26) will be included but must have a responsible caregiver or spouse present during the informed consent * Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months Exclusion Criteria: * Patients with a bleeding disorder that would contraindicate the performance of a muscle biopsy, such as a history of clinically significant bleeding diathesis (i.e., Hemophilia A or B, Von Willebrand's Disease, or congenital Factor VII deficiency) * Patients with a complex atherosclerotic lesion such that withholding medication creates disproportionate risk * Women currently taking hormone replacement therapy * Any other condition or event considered exclusionary by the PI and faculty physician

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease peripheral arterial disease

As listed by the trial registrant

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

Inflammation (D007249) Oxidative stress (D018384) Peripheral artery disease (D058729)

Contacts and locations

Locations

  • University of Utah Dept of Vascular Surgery

    Salt Lake City, Utah, 84132, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001, United States