Improving Mobility After Revascularization in Peripheral Artery Disease
Public ClinicalTrials.gov record NCT06686121. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06686121
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 386 participants
Conditions and interventions
Conditions
Interventions
- Home Based Exercise Behavioral
- Nitrate Rich Beetroot Juice Drug
- Attention Control Behavioral
- Placebo Beetroot Juice Without Nitrate Drug
Behavioral · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 3, 2025
- Primary completion
- Jan 31, 2032
- Completion
- Jul 31, 2032
- Last update posted
- Aug 25, 2025
2025 – 2032
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | Not yet recruiting |
| Rancho Research Institute | Downey | California | 90242 | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | 30307 | Not yet recruiting |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | Recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | Not yet recruiting |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06686121, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2025 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06686121 live on ClinicalTrials.gov.