11 Participants Needed

Special Shoes for Peripheral Arterial Disease

(PAD Trial)

HR
SA
Overseen BySara A Myers, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing special shoes for patients with PAD to help them walk better and with less pain. The shoes provide an extra boost with each step, which can improve mobility and quality of life for these patients.

Research Team

SA

Sara A. Myers, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for individuals who can consent, have chronic leg pain during exercise due to PAD with an ankle brachial index below 0.90, and stable blood pressure, cholesterol, and diabetes management. It's not for those with severe PAD causing rest pain or tissue loss, recent ischemic events in the legs from clots or trauma, or walking issues caused by other health problems.

Inclusion Criteria

Be able to give written, informed consent
My blood pressure, cholesterol, and diabetes treatments have been stable for 6 weeks.
Your ankle brachial index at rest is less than 0.90.
See 1 more

Exclusion Criteria

I have severe leg pain or tissue loss due to poor blood flow.
I recently had a blood clot or injury affecting my leg.
My ability to walk is limited due to conditions not related to leg pain from walking.

Treatment Details

Interventions

  • Assistive tennis shoes
Trial OverviewThe study tests special assistive tennis shoes designed for people with Peripheral Artery Disease (PAD) to see if they help reduce pain and increase physical activity compared to standard shoes. The goal is to improve daily living activities and potentially decrease related health risks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Progressive improvement in walking performanceExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

University of Nebraska

Collaborator

Trials
563
Recruited
1,147,000+