Special Shoes for Peripheral Arterial Disease

(PAD Trial)

Overseen By Sara A Myers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Rest pain, Acute ischemic event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests special shoes designed to assist people with peripheral artery disease (PAD), a condition that reduces blood flow to the legs, causing pain and difficulty walking. The goal is to determine if these assistive tennis shoes can reduce pain and increase activity levels compared to regular shoes. Participants should experience chronic leg pain when walking due to PAD and have been on a stable treatment plan for at least six weeks. If successful, these shoes could provide a new way to help Veterans with PAD improve their daily lives. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly enhance mobility and quality of life for those with PAD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your blood pressure, lipid, and diabetes medications be stable for 6 weeks before joining.

What prior data suggests that these assistive shoes are safe for patients with peripheral artery disease?

Research shows that special tennis shoes are generally safe for people with peripheral artery disease (PAD). Studies on similar shoes, such as those with curved soles for PAD and soft shoes for people with diabetes, indicate these shoes are usually well-tolerated. Reports of harm or serious side effects from wearing these types of shoes are rare. This suggests that these special shoes are likely safe for everyday use in managing PAD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these assistive tennis shoes for peripheral arterial disease (PAD) because they offer a novel approach by enhancing walking performance. Unlike standard treatments like medications or surgical interventions, these shoes are designed to physically support and improve mobility, potentially easing symptoms without invasive procedures. By providing a direct physical aid, they could offer an immediate benefit, increasing the distance and ease with which patients can walk, which is a significant quality of life improvement for those with PAD.

What evidence suggests that these assistive shoes are effective for peripheral artery disease?

Studies have shown that special tennis shoes can help people with peripheral artery disease (PAD) walk more easily. Research suggests these shoes may reduce pain and improve walking by providing better support and comfort. People with PAD often struggle to walk due to blocked leg arteries and poor blood flow. In this trial, participants will wear assistive tennis shoes for three months to evaluate their effectiveness in improving walking performance. Previous users of similar supportive shoes have reported positive experiences, noting improvements in their daily activities. Overall, these shoes might help increase physical activity, which is important for reducing health risks in people with PAD. ^{1 2 3 4 6}

Who Is on the Research Team?

Sara A. Myers, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including treadmill tests and preference evaluations for assistive shoes

1 week

1 visit (in-person)

Treatment

Participants use assistive shoes (CF or SL) for regular daily use to improve walking performance

12 weeks

Regular daily use

Follow-up

Participants are monitored for changes in physical activity, quality of life, and walking distance

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Assistive tennis shoes

Trial Overview The 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.

How Is the Trial Designed?

Group I: Progressive improvement in walking performance Experimental Treatment 1 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.

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+

Published Research Related to This Trial

Patients with peripheral artery disease reported positive experiences with the ankle-foot orthosis (AFO) in terms of usability and cost-effectiveness, indicating that the device was easy to use and had no out-of-pocket costs during the 3-month intervention.

Despite initial positive feedback, challenges related to motivation and the AFO's impact on daily activities led to lower compliance after the intervention, highlighting the need to address patients' perceptions to improve long-term use and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. Bashir, AZ., Dinkel, DM., Pipinos, II., et al.[2023]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/37387?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Improving Walking in Peripheral Artery Disease The investigators hypothesize that assistive shoes (CF and SL) will lead to improved walking performance in patients with PAD as compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9836764/

Long-term use of an ankle-foot orthosis intervention in patients ... Efficacy of ankle-foot orthoses on walking ability in peripheral artery disease. Vascular Medicine. 2019. Aug;24(4):324–31. [DOI] [PubMed] [Google Scholar] ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9770883/

EFFECTS OF ASSISTIVE TENNIS SHOES ON GROUND ... This study aims to examine how the CF and SL shoes impact walking performance in patients with PAD. A total of ten patients with PAD performed a progressive ...

4. researchgate.net researchgate.net/publication/366474760_EFFECTS_OF_ASSISTIVE_TENNIS_SHOES_ON_GROUND_REACTION_FORCE_FOR_PATIENTS_WITH_PERIPHERAL_ARTERY_DISEASE_DURING_WALKING

effects of assistive tennis shoes on ground reaction force ... Our results suggest that patients with PAD walked slower with less hip extension during propulsion. Significant force and power reductions were observed in knee ...

5. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-9-2021-81adc

Special Shoes for Peripheral Arterial Disease (PAD Trial) Patients with peripheral artery disease reported positive experiences with the ankle-foot orthosis (AFO) in terms of usability and cost-effectiveness, ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001251

2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/ ... Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON ...