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:

• You are 50 years of age or older.
• You have been diagnosed with peripheral artery disease (PAD), which is reduced blood flow to the legs — confirmed by a specific blood pressure test in the ankle or toe, or by imaging that shows a significant blockage in a leg artery, or by a drop in ankle blood pressure after a heel-rise exercise test.

Who may not be able to join:

• You have had an amputation of part or all of either leg.
• You have very severely reduced blood flow to your legs along with pain at rest (confirm with trial site).
• You use a wheelchair or need a walker to get around.
• Your ability to walk is mainly limited by something other than PAD.
• You currently have an open sore or ulcer on the bottom of your foot.
• You are unwilling to drink beetroot juice as part of the study.
• You are unwilling to be randomly assigned to either a home-based or supervised exercise program.
• You are planning to start a new walking exercise routine outside of the study, or are unwilling to avoid new walking exercise during the trial.
• You are already exercising at a level that matches what the study's exercise program would involve.
• You have end-stage kidney disease and are currently on dialysis.
• You are planning to have major surgery or a procedure to improve blood flow to your heart or legs in the next six months.
• You have had major surgery, a heart or leg procedure, or a serious heart-related event in the past three months.
• You have a serious medical condition such as lung disease requiring oxygen use during the day, Parkinson's disease, a life-threatening illness with less than six months to live, or have received cancer treatment in the past two years. (Note: people treated for an early-stage cancer with an excellent outlook, or who only need oxygen at night, may still qualify — confirm with trial site.)
• You scored below 23 on a standard memory and thinking test, or have been diagnosed with dementia. (Note: exceptions may be made if a lower score is due to language or education factors — confirm with trial site.)
• You are allergic to beetroot juice.
• You are currently consuming beetroot juice, beetroot supplements, or certain nitrate/nitrite products, and are unwilling to stop during the study. If you eat one cup or more of beets daily and are unwilling to stop for 30 days before the study and throughout it, you would not be eligible.
• You are currently experiencing unstable chest pain (unstable angina).
• You had an abnormal result on a pre-study stress test and have not been cleared for exercise by a doctor.
• You do not speak English, as the study team is only able to communicate in English and all study materials are in English only.
• You have taken part in or finished another clinical trial in the past three months. (Note: specific timeframes apply depending on the type of trial — confirm with trial site.)
• You have a vision problem that limits your ability to walk.
• Your resting blood pressure is below 100/45.
• You have taken part in a supervised treadmill exercise program or cardiac rehabilitation in the past three months.
• You use a mouthwash that kills bacteria (such as one containing chlorhexidine or cetylpyridinium chloride) and are unwilling to stop using it.
• Your kidney function test (eGFR) result is below 30, or your blood potassium level is above 5.0.
• You have a history of kidney stones that requires you to limit your intake of oxalate (a substance found in beetroot).
• The study investigators determine, based on their judgment, that the trial may not be safe or appropriate for you.

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