NCT06686121 Improving Mobility After Revascularization in Peripheral Artery Disease
| NCT ID | NCT06686121 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Northwestern University |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 386 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2032-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 386 participants in total. It began in 2025-08-04 with a primary completion date of 2032-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).
Eligibility Criteria
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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06686121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06686121 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 386 participants.
Is NCT06686121 currently recruiting?
Yes, NCT06686121 is actively recruiting participants. Contact the research team at mdm608@northwestern.edu for enrollment information.
Where is the NCT06686121 trial being conducted?
This trial is being conducted at Tucson, United States, Downey, United States, Atlanta, United States, Chicago, United States and 3 additional locations.
Who is sponsoring the NCT06686121 clinical trial?
NCT06686121 is sponsored by Northwestern University. The trial plans to enroll 386 participants.