Improving Walking in Peripheral Artery Disease

NCT05103280 | Completed Results

• 2 other identifiers: F3877-PI21RX003877
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral artery disease

Outcome Measures

Primary Outcomes (2)

• Changes in Walking Distance After Three-months Intervention

  In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.

  Baseline and after three-months intervention

• Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants

  At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates "Low comfort" and 10 indicates "High comfort." During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.

  Baseline

Secondary Outcomes (4)

• Changes in Vertical Ground Reaction Force After Three-months Intervention

  Baseline and after three-months intervention

• Changes in Muscle Oxygenation After Three-months Intervention

  Baseline and after three-months intervention

• Changes in Physical Activity After Three-months Intervention

  Baseline and after three-months intervention

• Changes in Rate of Perceived Exertion Score After Three-months Intervention

  Baseline and after three-months intervention

Study Arms (1)

Progressive improvement in walking performance

EXPERIMENTAL

A total of ten patients with peripheral artery disease will be enrolled for this arm and wear the assistive tennis shoes for three-months as an intervention.

Other: Assistive tennis shoes

Interventions

Assistive tennis shoes OTHER

Assistive shoes include carbon-fiber and spring loaded shoes.

Progressive improvement in walking performance

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Nebraska: collaborator

Study Sites (1)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Sara A. Myers, PhD - Professor
• Organization: University of Nebraska at Omaha

samyers@nebraska.edu; ffallahtafti@unomaha.edu

(402) 554-3246

Study Officials

• Sara A. Myers, PhD

  Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Ten patients will wear assistive shoes for 3 months.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 2, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The de-identified, anonymized dataset will only be shared after the completion of the study and publishing the outcomes in peer-reviewed journals and conference proceedings.

Locations

US (1)