Low-dose colchicine for people with peripheral artery disease to reduce heart and limb risks
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-11418068 · Data updated 2026-11-12
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.
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 | 2026 |
| Award (this year) | $651,978 |
| NIH project number | 5U24HL171356-03 |
| Project ID | NIH-11418068 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults with peripheral artery disease eligible for a multinational, randomized colchicine trial.
✕Less likely to help
Patients not at risk of inflammation-related complications or those with contraindications to colchicine may not benefit.
What this research studies
If you have PAD, this program will involve a global, randomized trial comparing a small daily tablet of colchicine to a placebo to see if it can reduce cardiovascular and limb-related events. The US portion includes 1,000 participants across a coordinated Clinical Coordination Center and Statistical/Data Coordination Center led by Duke University, with strong patient advocacy input. The study emphasizes careful tracking of health outcomes, inflammation markers, and adverse effects over several years. Participation would contribute to evidence that could change how PAD is managed in the future.
Why it matters
Potential benefit: If successful, the trial could lead to a new, accessible treatment option to lower heart and limb risks for PAD patients.
How similar studies have gone: Prior research suggests anti-inflammatory treatment may lower cardiovascular events in related conditions, supporting the rationale for this PAD-focused trial.
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.
-
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 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.
-
IMProving mobility After revasCularizaTion in Peripheral Artery Disease
This study tests whether home-based exercise plus a nitrate supplement can help people with leg artery disease walk farther after a vascular procedure.
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.