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Improving Mobility After Revascularization in Peripheral Artery Disease
NCT06686121 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL Home Based Exercise
- DRUG Nitrate Rich Beetroot Juice
- DRUG Placebo Beetroot Juice Without Nitrate
Study Locations (7)
Illinois
- Northwestern University Feinberg School of Medicine — Chicago
- University of Chicago — Chicago
Arizona
- University of Arizona — Tucson
California
- Rancho Research Institute — Downey
Georgia
- Emory University School of Medicine — Atlanta
New Hampshire
- Dartmouth Hitchcock Medical Center — Lebanon
Pennsylvania
- University of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2025-08-04 |
| Est. Completion | 2032-08-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06686121
The ClinicalTrials.gov registry entry for NCT06686121 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,033 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 4 interventions — of which Attention Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06686121 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Illinois, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06686121 about?
NCT06686121 is a clinical study titled "Improving Mobility After Revascularization in Peripheral Artery Disease". 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...
What is the current status of trial NCT06686121?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2025-08-04. Estimated completion is 2032-08-01.
What conditions does trial NCT06686121 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Mobility Limitation, Peripheral Vascular Disease, Intermittent Claudication, Revascularization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06686121?
The interventions under investigation include: Attention Control (BEHAVIORAL), Home Based Exercise (BEHAVIORAL), Nitrate Rich Beetroot Juice (DRUG), Placebo Beetroot Juice Without Nitrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06686121?
This trial is sponsored by Northwestern University, which has 1,033 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06686121 being conducted?
This trial has 7 study locations across Arizona, California, Georgia, Illinois, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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