Early Phase 1 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:

For people with peripheral artery disease (PAD) — reduced blood flow to the legs:

• People who are able to sign a written consent form agreeing to take part
• People aged between 50 and 75 years
• People diagnosed with PAD at a stage where walking causes leg pain (Fontaine stage II or III)
• People who have a history of leg pain brought on by exercise or walking
• Women who have gone through menopause, meaning periods stopped more than 24 months ago
• People whose kidneys are working normally, or have shown stable kidney function in the last 6 months (confirm with trial site)
• People whose liver is working normally, or have shown stable liver function in the last 6 months (confirm with trial site)
• People whose blood test results fall within the normal ranges for red blood cells, haemoglobin, white blood cells, platelets, and lymphocytes — or have shown stable blood counts in the last 6 months (confirm with trial site)

For healthy comparison participants (age-matched controls):

• People who are able to sign a written consent form agreeing to take part
• People aged between 50 and 75 years
• People with no sign of blocked or narrowed arteries in the legs, as measured by a standard blood pressure comparison test
• Women who have gone through menopause, meaning periods stopped more than 24 months ago
• People whose kidneys are working normally, or have shown stable kidney function in the last 6 months (confirm with trial site)
• People whose liver is working normally, or have shown stable liver function in the last 6 months (confirm with trial site)
• People whose blood test results fall within the normal ranges for red blood cells, haemoglobin, white blood cells, platelets, and lymphocytes (confirm with trial site)

Who may not be able to join:

For people with PAD:

• People whose PAD causes pain while resting, or has led to tissue damage, wounds, ulcers, gangrene, or skin death in the foot (the most severe stage of PAD)
• People who have had a sudden blockage or injury causing reduced blood flow to a leg
• People whose walking is limited by conditions other than PAD
• People who have not had a physical examination to assess their ability to exercise in the past year
• People who are currently pregnant or breastfeeding
• People whose kidney or liver function test results are outside the normal ranges
• People diagnosed with multiple sclerosis or psoriasis
• People diagnosed with certain gut conditions, such as moderate irritable bowel syndrome or Crohn's disease
• People currently taking a medication called dimethyl fumarate
• People who have had an allergic reaction to diroximel fumarate, dimethyl fumarate, or any ingredient in the medication VUMERITY
• People whose blood test results fall outside the required normal ranges

For healthy comparison participants:

• People who have been diagnosed with PAD
• People who have not had a physical examination to assess their ability to exercise in the past year
• People whose last physical examination identified any limitations to exercise
• People whose walking ability is limited due to a muscle or joint injury
• People who are currently pregnant or breastfeeding
• People whose kidney function test results are outside the normal ranges
• People whose liver function test results are outside the normal ranges
• People whose blood test results fall outside the required normal ranges

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