N/A
N=10
Improving Walking in Peripheral Artery Disease
Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT05103280 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Changes in Walking Distance After Three-months Intervention — 289.68; 262.95 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assistive tennis shoes (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Walking Distance After Three-months Intervention |
289.68; 262.95 | — |
| PRIMARY Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants |
5.5; 5.9; 6.6 | — |
| SECONDARY Changes in Vertical Ground Reaction Force After Three-months Intervention |
769.34; 845.38 | — |
| SECONDARY Changes in Muscle Oxygenation After Three-months Intervention |
36.82; 40.02 | — |
| SECONDARY Changes in Physical Activity After Three-months Intervention |
4099.102; 4740.85 | — |
| SECONDARY Changes in Rate of Perceived Exertion Score After Three-months Intervention |
12.6; 13.25 | — |
Summary
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. The risk of mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within 3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of specially designed assistive shoes in patients with PAD and to determine if there are any potential benefits of using these shoes over standard shoes. These assistive shoes may enable patients to carry out desired activities of daily living with less pain and more physical activity. Increasing physical activity will decrease morbidity and mortality. If proven beneficial, the findings will lead to a novel and conservative rehabilitation protocol that directly benefits Veterans nationwide.
Eligibility Criteria
Inclusion Criteria
At entry into the study, all patients must:
- be able to give written, informed consent
- demonstrate positive history of chronic claudication
- have an ankle brachial index < 0.90 at rest
- have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
Exclusion Criteria
Any potential subjects will be excluded if they have:
- rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV)
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Data sourced from ClinicalTrials.gov (NCT05103280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.