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Can a common gout drug help unclog leg arteries?

NCT ID NCT06212271

Disease control Sponsor: University of Pennsylvania 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether colchicine, a drug used for gout, can reduce inflammation in the leg arteries of people with peripheral artery disease (PAD). Twenty-four adults with PAD received either colchicine or a placebo. Researchers used special scans and blood tests to measure changes in artery inflammation and also asked participants about their walking ability.

What this could mean

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

Active substance
colchicine
What this could lead to
If it works, this could point toward a way to reduce artery inflammation and improve walking ability in people with peripheral artery disease.
What could go wrong
This is a very small, early-phase trial with only 24 participants. The results may not apply to everyone, and colchicine can cause side effects like stomach upset.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

24 people

The number who actually took part.

Started

Sep 2024

Finished

Mar 2026

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 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. Age \>= 18 years 2. Diagnosis of peripheral artery disease 3. Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: 1. Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months 2. Allergy to colchicine 3. Presence of medication with drug-drug interaction 4. Acute limb ischemia requiring emergent intervention 5. Autoimmune/autoinflammatory disorders affecting blood vessels or with planned need for systemic anti-inflammatory medication 6. Recent (\<14 days) systemic infection requiring hospitalization or ongoing treatment with antimicrobials 7. History of persistent anemia, thrombocytopenia, or neutropenia requiring hematology/oncology treatment or felt to pose unacceptable risk to colchicine by the principal investigator 8. Pregnant or lactating women 9. History of uncontrolled diabetes or an A1C \>10% prior to the baseline visit 10. History of CrCl \< 30 mL/minute or eGFR \< 30mL/minute or end-stage renal disease ESRD on dialysis 11. History of liver disease or chronically-elevated (\>3 months) ALT/AST \> 3.0 x ULN 12. Claustrophobia

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Conditions

The condition(s) this trial relates to.

atherosclerosis Inflammation peripheral arterial disease

As listed by the trial registrant

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

Peripheral artery disease

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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