Phase 3 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older
• People who have been diagnosed with chronic limb-threatening ischemia (a serious condition where reduced blood flow to a limb causes severe symptoms), confirmed by imaging such as a scan or ultrasound taken within the past 12 months
• People whose blood flow measurements in their ankle or toe fall below certain levels, indicating significantly reduced circulation (confirm with trial site for specific values)
• People experiencing rest pain (pain in the limb even while resting) or tissue loss such as a non-healing wound or gangrene, with blood flow measurements confirming reduced circulation
• People who have recently had a successful procedure to restore blood flow to the affected leg — either a surgical bypass or a minimally invasive (endovascular) procedure — within the last 7 days before joining the trial
• People whose restored blood flow has been confirmed by imaging after the procedure, with at least one clear pathway of blood reaching the foot
• People for whom no further immediate procedure on that leg is planned
• People who are willing and able to follow the study requirements, attend follow-up visits, complete all assessments, and sign a consent form

Who may not be able to join:

• People under 18 years of age
• People who had their procedure for less severe disease (mild or no symptoms)
• People who have severe tissue loss where a major amputation was already planned at the time of screening
• People in whom blood flow to at least one artery below the knee could not be restored after the procedure
• People who experienced a sudden, severe loss of blood flow to a limb within 2 weeks before screening
• People showing signs of a serious, uncontrolled infection or bloodstream infection at the time of screening — such as high fever, a very high white blood cell count, or low blood pressure (note: certain limited foot infections may not automatically exclude someone — confirm with trial site)
• People with unstable circulation after their revascularization procedure
• People who cannot tolerate any blood-thinning antiplatelet medication, or who have a serious bleeding disorder
• People who had a heart attack, stroke, or were hospitalised for heart failure within 30 days before screening
• People who have a known reason they cannot take the medication colchicine, or who already need to take colchicine for another condition
• People taking certain other medications that are known to interact with colchicine (confirm with trial site for specific medicines)
• People with active hepatitis or severe liver disease
• People who are pregnant, breastfeeding, or able to become pregnant and not using effective contraception
• People who are currently taking part in, or have taken part in, another clinical trial involving an investigational medicine within the last 30 days
• People whose life expectancy is less than one year

Important: Always verify eligibility with the trial site directly before applying.