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Anti-inflammatory Agent

Colchicine for Peripheral Arterial Disease

Phase < 1
Recruiting
Led By Michael Levin, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic PAD
Require endarterectomy
Must not have
Presence of medication with drug-drug interaction
Vascular connective tissue disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging (week 4)

Summary

This trial will test the effects of reducing inflammation in clogged arteries in the leg. Patients will either receive a medication called colchicine or a fake treatment to see how colchicine affects the inflammation

Who is the study for?
This trial is for individuals with Peripheral Arterial Disease who are undergoing femoral endarterectomy. Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they qualify.
What is being tested?
The study aims to see if colchicine can reduce inflammation in the arteries of the leg compared to a placebo. Participants will be randomly assigned to receive either colchicine or a dummy pill without any active ingredients.
What are the potential side effects?
While specific side effects for this trial aren't listed, generally, colchicine can cause gastrointestinal issues like diarrhea and nausea, as well as potential risks of muscle pain and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have pain in my legs due to poor blood flow.
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I need surgery to remove plaque from my artery.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that interacts with other drugs.
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I have a disorder affecting my blood vessels and connective tissues.
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My diabetes is not under control (A1C >10%).
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My kidney function is very low or I am on dialysis.
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I need urgent treatment for a blocked artery in my limb.
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I have an autoimmune or autoinflammatory disorder.
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I have a body-wide infection.
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I have a blood disorder.
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My liver is not functioning properly, or my liver tests are high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging (week 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging (week 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Molecular imaging markers of inflammation
Secondary study objectives
Circulating markers of inflammation
Patient-reported walking impairment

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981
1%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Colchicine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study.
Group II: PlaceboPlacebo Group1 Intervention
This arm is a matching placebo that will be administered in the same fashion as the experimental arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
2014
Completed Phase 4
~18130

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,822 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
1,378 Patients Enrolled for Peripheral Arterial Disease
Doris Duke Charitable FoundationOTHER
64 Previous Clinical Trials
264,386 Total Patients Enrolled
Michael Levin, MDPrincipal InvestigatorUniversity of Pennsylvania
~16 spots leftby Jan 2026
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