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Smart shoes could ease walking pain for millions

NCT ID NCT04337554

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested special exoskeleton footwear designed to assist walking in people aged 40 and older with peripheral artery disease (PAD). Researchers compared different levels of assistance to see which worked best for comfort and walking performance. The study included 47 participants and measured how the shoes affected walking mechanics, muscle oxygen, and energy use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Exoskeleton footwear (assistive device)
What this could lead to
If successful, this device could help people with peripheral artery disease walk more easily and with less discomfort.
What could go wrong
This is a small, early-stage study focused on finding the best assistance level, not proving long-term benefits. The device may not work for everyone or be practical for daily use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

47 people

The number who actually took part.

Started

Aug 2020

Finished

Sep 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Omaha VA Medical Center

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion criteria for healthy older: At entry into the study, all subjects must: * Be able to give written, informed consent * Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks as determined by a health history questionnaire * Be 40 years of age or older * Healthy aged selected to match the population of patients with PAD * Demonstrate negative history of chronic claudication or other exercise limitation as determined by a health history questionnaire Inclusion criteria for patients with PAD: At entry into the study, all subjects must: * Meet criteria 1-3 from above * Demonstrate positive history of chronic claudication pain * Demonstrate exercise-limiting claudication per history and direct observation * Have evidence of occlusive disease on ankle/brachial index testing and/or computerized tomographic angiography Exclusion Criteria: Exclusion criteria for healthy older, any potential subjects will be excluded if they have: * An ankle-brachial index \< 0.90 at rest, as measured by the study team * Healthy subjects only * Individuals without symptoms but with reduce blood flow (asymptomatic PAD) will be excluded * Walking capacity limited by conditions affecting the legs (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

Contacts and locations

Locations

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

    Omaha, Nebraska, 68105-1850, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.