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 who have had a successful procedure to restore blood flow in a leg artery for a condition called peripheral artery disease (PAD) that was causing significant walking difficulties, where the procedure was done at least 30 days before initial testing and between 30 and 100 days before being assigned to a study group.

Who may not be able to join:

• People who have had a leg amputation (not including toe or partial foot amputation)
• People with active gangrene (severe tissue death due to infection or lack of blood flow)
• People with a serious, active condition where a limb is in immediate danger due to lack of blood supply
• People who are already exercising at a level similar to what the study exercise program involves (determined by the study investigator)
• People with unstable angina (unpredictable chest pain related to the heart)
• People who are unwilling to drink the study beverages
• People who are unwilling to follow the study program or complete all required follow-up tests
• People currently taking sildenafil, tadalafil, or similar medications
• People who are unwilling to be randomly placed into either study group (a home-based exercise group or an attention control group)
• People who are currently consuming beetroot juice, beetroot supplements, or oral nitrate or nitrite products, and who are unwilling to stop taking these for 30 days before initial testing and throughout the entire study
• People with a history of kidney stones that requires them to limit oxalate (a naturally occurring substance found in beets and other foods) in their diet
• People whose resting blood pressure reading is below 100/45
• People who use a wheelchair full-time or require a walker to walk
• People whose walking ability is limited by a condition other than PAD
• People with a current foot ulcer
• People who have major surgery, a heart procedure, or a leg artery procedure planned in the next 12 months
• People with serious medical conditions, including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness where life expectancy is less than six months
• People with an allergy to beetroot juice
• People who currently eat one cup or more of beets daily and are unwilling to reduce this to less than one cup per day for 14 days before initial testing and throughout the study
• People who have participated in or completed another clinical trial in the previous three months (the study investigator will use their judgment in some cases)
• People with a visual impairment that affects their ability to walk
• People who are unable to communicate in English or Spanish, or who speak Spanish but are enrolled at a site that cannot deliver the program in Spanish
• People who use a mouthwash containing chlorhexidine or cetylpyridinium chloride, or any mouthwash identified as bacteria-killing, and who are unwilling to stop using it
• People who plan to start a supervised treadmill exercise program in the next 12 months
• People who have had a heart attack or stroke in the three months before initial testing
• People whom the study investigator determines the trial would be unsafe for or not a suitable fit (confirm with trial site)

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