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NCT05103280 · ClinicalTrials.gov registry record · NA

Improving Walking in Peripheral Artery Disease

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT05103280: Completed NA study, sponsored by VA Office of Research and Development.

NCT05103280 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05103280, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Assistive tennis shoes

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-10-01
Est. Completion 2024-09-30
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT05103280 record still lists

NCT05103280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Assistive tennis shoes is the first listed.

NCT05103280 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05103280 about?

NCT05103280 is a clinical study titled "Improving Walking in Peripheral Artery Disease". 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 O...

What is the current status of trial NCT05103280?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-10-01. Estimated completion is 2024-09-30.

What interventions are being tested in trial NCT05103280?

The interventions under investigation include: Assistive tennis shoes (OTHER).

Who is sponsoring clinical trial NCT05103280?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05103280's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05103280, the US trial registry maintained by the National Library of Medicine. NCT05103280 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.