Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease

Last updated: July 16, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

1

Condition

Claudication

Peripheral Arterial Occlusive Disease

Peripheral Arterial Disease (Pad)

Treatment

Placebo

Colchicine

Clinical Study ID

NCT06212271
854429
  • Ages > 18
  • All Genders

Study Summary

The goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. Researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >= 18 years

  2. Diagnosis of peripheral artery disease

  3. Stated willingness to comply with all study procedures and availability for theduration of the study

Exclusion

Exclusion Criteria:

  1. Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in thepast 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 needfor systemic anti-inflammatory medication

  6. Recent (<14 days) systemic infection requiring hospitalization or ongoing treatmentwith antimicrobials

  7. History of persistent anemia, thrombocytopenia, or neutropenia requiringhematology/oncology treatment or felt to pose unacceptable risk to colchicine by theprincipal 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 ESRDon dialysis

  11. History of liver disease or chronically-elevated (>3 months) ALT/AST > 3.0 x ULN

  12. Claustrophobia

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
September 25, 2024
Estimated Completion Date:
January 31, 2026

Study Description

Patients with peripheral artery disease who will be undergoing femoral endarterectomy will be randomized 1:1 to receive colchicine (0.6mg oral) or placebo daily for 4 weeks prior to 18F-FDG PET/CT imaging. At the baseline visit, study procedures will be reviewed with eligible participants and the study team will obtain written informed consent. Baseline blood samples for laboratory studies will be collected and assayed, as well as additional blood samples for research. Participants will completed study questionnaires at baseline and at the imaging visit. Participants will receive follow-up phone calls with the study team. All eligible participants will be approached for participation in an imaging visit. At the imaging visit, participants will repeat laboratory tests and undergo non-invasive molecular imaging to evaluate the effects of colchicine on the extent of atherosclerotic plaque macrophage activity as assessed by 18F-FDG PET/CT.

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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