Condition: Peripheral Artery Disease · Intermittent Claudication · Peripheral Vascular Disease · Sponsor: Northwestern University
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…
This description comes directly from the study's public registry record.
Mary M McDermott, MD · 312-503-6438 · mdm608@northwestern.edu
Always discuss trial participation with your own doctor first.
| University of Arizona | Tucson, Arizona, United States | Not Yet Recruiting |
| Rancho Research Institute | Downey, California, United States | Recruiting |
| Emory University School of Medicine | Atlanta, Georgia, United States | Not Yet Recruiting |
| Northwestern University Feinberg School of Medicine | Chicago, Illinois, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, United States | Not Yet Recruiting |
| University of Pittsburgh | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06686121