Low-dose colchicine for people with peripheral artery disease
Official title: 2/2 Low dose colchicine in pAtients with peripheral artery DiseasE to assess residual vascular risk (LEADER-PAD)
Funded at Duke University · NIH-11399633 · Data updated 2026-11-12
People with peripheral artery disease will take a daily low-dose colchicine pill or a placebo to see if it lowers their risk of heart attacks, strokes, and limb problems.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | September 25, 2024 |
| Project end | August 31, 2029 |
| Funding year | 2025 |
| Award (this year) | $120,557 |
| NIH project number | 3U24HL171356-02S1 |
| Project ID | NIH-11399633 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with a medical diagnosis of peripheral artery disease who can take an oral medication and attend scheduled study visits would be the best candidates.
✕Less likely to help
People without PAD or those with contraindications to colchicine—such as severe kidney or liver disease, certain drug interactions, or pregnancy—may not be eligible or receive benefit.
What this research studies
You would be randomly assigned to take 0.5 mg of colchicine each day or a matching placebo, and neither you nor the study team would know which one you receive (double-blind). The U.S. effort plans to enroll 1,000 participants as part of a 6,150-person international, randomized, placebo-controlled trial led by Duke and partner centers. Study staff will follow participants with clinic visits and medical record checks to track heart attacks, strokes, limb events (such as procedures or amputations), and side effects. The trial tests whether a widely available, low-cost anti-inflammatory pill can lower vascular risks for people with PAD.
Why it matters
Potential benefit: If successful, this common and inexpensive medicine could lower the chances of heart attacks, strokes, and serious limb complications in people with PAD.
How similar studies have gone: Large trials in people with coronary artery disease have shown colchicine reduced combined cardiovascular events by about 25%, but a large dedicated PAD trial like this is new.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Vemulapalli, Sreekanth — Duke University
- Study coordinator: Vemulapalli, Sreekanth
Related research
Other NIH-funded projects on the same topics.
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Low-dose colchicine to reduce vascular risk in people with peripheral artery disease
This project tests whether taking a low-dose anti-inflammatory drug (colchicine) daily can lower heart and limb-related risks for adults with peripheral artery disease.
-
Gamified home walking program to help seniors with peripheral artery disease improve walking and quality of life
A program uses game elements on wearable devices to help people 65+ with peripheral artery disease walk more at home and feel better.
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Fatty clues in leg arteries: how fat burning in mitochondria affects PAD and muscle health
This project looks at how fat metabolism in leg muscles relates to weakness and tissue damage in people with peripheral artery disease and aims to find new ways to help them.
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Enhancing muscle energy to help leg function in PAD
A study to boost how muscle mitochondria work in people with peripheral artery disease to improve walking and leg function.
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Low-dose colchicine for people with peripheral artery disease to reduce heart and limb risks
A large international study will test whether a low daily dose of colchicine can lower heart and limb complications for people with peripheral artery disease.
-
Low-dose colchicine for reducing vascular risk in people with PAD
A large international study will test whether a daily low dose of colchicine can lower heart and limb-related risks for people with peripheral artery disease.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.