Testing Colchicine to Reduce Complications and Improve Outcomes After Leg Blood Flow Procedures in Adults with Severe Peripheral Artery Disease in Asia

What this Trial Is About

Researchers are studying chronic limb-threatening ischemia CLTI, a severe form of peripheral artery disease where narrowed arteries reduce blood flow to the legs, causing pain, wounds, or gangrene. This condition carries a high risk of leg amputation and death, and complications often persist even after procedures to restore blood flow. The study evaluates whether colchicine, an anti-inflammatory drug used for gout and heart disease, can improve outcomes for CLTI patients after revascularization. Participants who have recently undergone a successful procedure to restore blood flow to their leg will be randomly assigned to receive either colchicine 0.5 mg daily or a matching placebo for 12 months, alongside their usual medications. Treatment starts within 7 days of the procedure. Dose adjustments or temporary treatment interruptions are allowed for side effects. The study is double-blind and conducted at multiple centers in Taiwan. During the 12 months of participation, patients will have regular assessments including blood flow tests, wound healing evaluations, and quality of life questionnaires. Researchers will monitor safety and measure outcomes such as amputation-free survival, major limb and cardiovascular events, and inflammation markers. This pilot study aims to provide initial evidence on the potential benefits and safety of colchicine in CLTI patients to guide future larger trials.

Colchicine in Chronic Limb-Threatening Ischemia