Phase 2 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 a low ankle-brachial index (ABI) score of 0.90 or below — this is a simple test comparing blood pressure in the ankle and arm to check blood flow in the legs.
• People who have laboratory or imaging evidence of peripheral artery disease (PAD), such as reduced blood pressure readings in the toes or ankles, or a scan showing a significant blockage (at least 70%) in an artery supplying the legs.
• People with an ABI score between 0.90 and 1.00 whose ABI drops by 20% or more in either leg after a heel-rise exercise test.

Who may not be able to join:

• People who have had an amputation of part or all of a leg.
• People with severely reduced blood flow to a limb (ABI below 0.40) who also have pain in the legs while resting.
• People who use a wheelchair full-time or need a walker to get around.
• People whose ability to walk is limited by a condition other than PAD.
• People who currently have an open sore (ulcer) on the bottom of their foot.
• People who do not complete the study's required run-in period before the main trial begins.
• People who are not willing to be randomly placed into either the supervised exercise group or the attention control group.
• People who are planning to start a new walking exercise routine outside of the study, or who are not willing to avoid starting new walking exercise during the trial.
• People who are already exercising at a level similar to what the exercise program in this trial would involve (as judged by the investigator).
• People with end-stage kidney disease who are currently receiving haemodialysis (kidney dialysis).
• People who have major surgery, heart procedure, or a leg artery procedure planned within the next six months.
• People who have had major surgery, a heart procedure, a leg artery procedure, or a serious heart event in the past three months.
• People with serious ongoing health conditions, including lung disease requiring oxygen use during the day, Parkinson's disease, a life-threatening illness with less than six months to live, or cancer that required treatment in the past two years. (People who had treatment for an early-stage cancer with an excellent outlook, or who only need oxygen at night, may still be considered — confirm with trial site.)
• People who score below 23 on a standard memory and thinking test (MMSE), or who have dementia that would prevent full participation. (A lower score due to language or education differences may be considered differently at the investigator's discretion — confirm with trial site.)
• People who are allergic to beetroot juice.
• People who are currently consuming beetroot juice, beetroot supplements, or oral nitrate or nitrite products, and who are not willing to stop these for 30 days before the study begins and throughout the trial.
• People who currently eat one cup or more of beets per day and are not willing to stop this level of beet consumption for 30 days before the study and during the trial.
• People with unstable angina (unpredictable or worsening chest pain).
• People who had an abnormal result on a pre-study exercise stress test and have not received clearance from a doctor to exercise.
• People who do not speak English, as the trial's programs are delivered only in English and the trial does not have multilingual staff or translated materials.
• People who have participated in or completed another clinical trial in the past three months. (Different waiting periods may apply depending on the type of trial previously completed — confirm with trial site.)
• People whose vision problems affect their ability to walk.
• People whose resting blood pressure reading is below 100/45.
• People who have participated in a supervised treadmill exercise program in the past three months, or who are planning to start one in the next six months.
• People who the investigator determines, for any other reason, may not be suited for or safe to participate in the trial.

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