AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Improving Mobility After Revascularization in Peripheral Artery Disease

RecruitingPhase 3Ages 18 Years - anyAllNorthwestern University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revas

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization. Exclusion Criteria: 1. History of leg amputation, not including toe and partial foot amputation 2. Active gangrene 3. Active limb threatening ischemia 4. Already exercising at a level consistent with exercise intervention, using investigator discretion. 5. Unstable angina 6. Unwilling to drink study beverages 7. Unwilling to adhere to the interventions and complete follow-up testing 8. Currently taking sildenafil, tadalafil, or related drugs. 9. Unwilling to accept randomization into either group (home-based exercise or attention control) 10. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial. 11. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial. 12. Baseline blood pressure \<100/45. 13. Wheelchair confinement or requiring a walker to ambulate 14. Walking is limited by a condition other than PAD 15. Current foot ulcer 16. Planned major surgery, coronary revascularization, or lower extremity revascularization during the next 12 months 17. Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months. 18. Allergy to beetroot juice 19. Currently consuming one cup or more of beets daily. Participants will be asked to decrease beet consumption to less than one cup of beets per day for 14 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial. 20. Participation in or completion of a clinical trial in the previous three months, using investigator discretion for trials that may not impact study participation or outcome measures of the IMPACT PAD Trial. 21. Visual impairment that limits walking ability. 22. Unable to communicate in English, unless the participant communicates in Spanish and is enrolled at a site that can deliver the intervention in Spanish. All sites with a Spanish speaking coordinator and interventionist will be able to enroll Spanish-speaking participants. While investigators aim to be as inclusive as possible, resources are not available to allow inclusion of people speaking languages that are not Spanish or English. 23. Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue. 24. Planning to begin a supervised treadmill exercise program in the next 12 months. 25. Heart attack or stroke in previous three months prior to baseline testing. 26. An eGFR value \<30 or potassium \>5.0. 27. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
๐Ÿ’Š

What it tests

  • Home Based Exercise
  • Nitrate Rich Beetroot Juice
  • Attention Control
  • Placebo Beetroot Juice Without Nitrate
๐Ÿ“

Where

8 sites
University of Arizona
Tucson, United States
Rancho Research Institute
Downey, United States
University of South Florida
Tampa, United States
Emory University School of Medicine
Atlanta, United States
Northwestern University Feinberg School of Medicine
Chicago, United States
University of Chicago
Chicago, United States
Henry Ford Health
Detroit, United States
Dartmouth Hitchcock Medical Center
Lebanon, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy