Peripheral Artery DiseaseEarly Phase 1NCT06212271
Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
A Early Phase 1 study testing Colchicine in people with Peripheral Artery Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2024to 25 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Diagnosis of peripheral artery disease
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
- Allergy to colchicine
- Presence of medication with drug-drug interaction
- Acute limb ischemia requiring emergent intervention
- Autoimmune/autoinflammatory disorders affecting blood vessels or with planned need for systemic anti-inflammatory medication
- Recent (<14 days) systemic infection requiring hospitalization or ongoing treatment with antimicrobials
Show all 12Show fewer
- History of persistent anemia, thrombocytopenia, or neutropenia requiring hematology/oncology treatment or felt to pose unacceptable risk to colchicine by the principal investigator
- Pregnant or lactating women
- History of uncontrolled diabetes or an A1C >10% prior to the baseline visit
- History of CrCl < 30 mL/minute or eGFR < 30mL/minute or end-stage renal disease ESRD on dialysis
- History of liver disease or chronically-elevated (>3 months) ALT/AST > 3.0 x ULN
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
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.
Read the detailed 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Colchicine, Placebo
- Keywords
- colchicine, atherosclerotic cardiovascular disease, peripheral artery disease, atherosclerosis, inflammation
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
See arm description.
PlaceboDrug
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study. Receives: Drug: Colchicine |
| Placebo | Placebo comparator | This arm is a matching placebo that will be administered in the same fashion as the experimental arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular imaging markers of inflammation
Extent of atherosclerotic plaque macrophage activity as assessed by FDG PET/CT
Measured: Imaging (Week 4)
Secondary outcomes (2)
Circulating markers of inflammation
Expression of plasma IL6 and hsCRP levels
Measured: Imaging (Week 4)
Patient-reported walking impairment
Walking impairment as reported by Walking Impairment Questionnaire
Measured: Imaging (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Sep 2024
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Levin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212271
- Sponsor's protocol ID
- 854429
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Mechanistic Clinical Trial of Colchicine in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06212271
- Acronym / sponsor ID
- 854429
- Conditions
- Peripheral Artery Disease
- Keywords
- colchicine, atherosclerotic cardiovascular disease, peripheral artery disease, atherosclerosis, inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineColchicine (0.6 mg oral daily for 4-weeks) will be the drug administered in this study. |
| Placebo | Placebo comparator | Drug: PlaceboThis arm is a matching placebo that will be administered in the same fashion as the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Diagnosis of peripheral artery disease
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (12 listed)
- Use of colchicine or systemic anti-inflammatory medication (eg. tocilizumab) in the past 3 months
- Allergy to colchicine
- Presence of medication with drug-drug interaction
- Acute limb ischemia requiring emergent intervention
- Autoimmune/autoinflammatory disorders affecting blood vessels or with planned need for systemic anti-inflammatory medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineSee arm description. | Drug | Colchicine |
| PlaceboSee arm description. | Drug | Placebo |
Primary outcome
Molecular imaging markers of inflammation
Time frame: Imaging (Week 4)
Extent of atherosclerotic plaque macrophage activity as assessed by FDG PET/CT
2 secondary outcomes
Circulating markers of inflammation
Time frame: Imaging (Week 4)
Patient-reported walking impairment
Time frame: Imaging (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Levin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Colchicine in people with Peripheral Artery Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular imaging markers of inflammation (time frame: Imaging (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.