Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

To be considered for this study, you need to be an adult (18 years or older) and have been diagnosed with Peripheral Artery Disease (PAD). This might mean you experience leg pain when walking that goes away with rest (intermittent claudication), or you've had an ankle-brachial index (ABI) test showing a low blood pressure reading in your ankle, or scans showing narrowed leg arteries.

You might also be eligible if you have more severe PAD symptoms, such as pain in your feet at rest, or wounds or gangrene on your legs or feet. If you have previously had surgery or a procedure to improve blood flow in your leg arteries, or if you've had an amputation due to circulation problems, you could also be included.

However, this study isn't for everyone. You wouldn't be able to take part if you have certain existing health conditions that could be affected by colchicine, such as severe kidney or liver problems, or if you're experiencing ongoing severe diarrhoea. If you're pregnant, breastfeeding, or planning to become pregnant during the study, this study isn't suitable. Also, if you're taking certain medicines that would react badly with colchicine, or if you already take colchicine for another condition, you wouldn't be able to join. The study is also not for those with a very short life expectancy.

If you decide to take part in the LEADER-PAD study, you will first have a health check to make sure the study is right for you. You would then be asked to sign a consent form, showing you understand what's involved. For an initial period, everyone will receive the active study medicine. After this, you would be randomly assigned to take either a low-dose colchicine tablet (0.5 mg) or a matching dummy pill (placebo) once a day. You won't know which one you're taking, and neither will your study doctor, as it's a 'blinded' study.

You would need to attend regular appointments at the study clinic. These visits will involve health checks, blood tests, and discussions about how you are feeling and if you've had any health events or concerns. You'll also be asked to keep track of any medicines you're taking. The study will continue for several years and you will be followed up for a number of years, but the exact duration for each participant can vary, depending on when they join and how the study progresses. All study medication and assessments will be provided at no cost, and your overall health will be closely monitored throughout the study.