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N/A N=10 Treatment

Improving Walking in Peripheral Artery Disease

Peripheral Artery Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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