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

11 Participants Needed

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.

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 data supports the effectiveness of the treatment Assistive tennis shoes for Peripheral Arterial Disease?

Research on rocker-soled shoes, which are similar to assistive tennis shoes, shows they can help people with calf claudication (pain due to poor blood flow) walk longer distances and reduce pain. This suggests that assistive tennis shoes might also be effective for people with peripheral arterial disease. ^{1 2 3 4 5}

Are special shoes for peripheral arterial disease safe for humans?

Studies on rocker-soled shoes for peripheral arterial disease and cushioned therapeutic footwear for diabetic patients suggest these shoes are generally safe and may help reduce pain and foot lesions. ^{2 5 6 7 8}

How do special shoes for peripheral arterial disease differ from other treatments?

Special shoes for peripheral arterial disease, like rocker-soled shoes, are unique because they are designed to reduce the workload on calf muscles, which can help increase walking distance and reduce symptoms of calf claudication (pain caused by too little blood flow during exercise). Unlike drugs or surgical options, these shoes offer a non-invasive way to improve mobility and quality of life for patients. ^{1 2 3 9 10}

Research Team

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.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A plantar flexion device exercise programme for patients with peripheral arterial disease: a randomised prospective feasibility study. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Unloading shoes for intermittent claudication: a randomised crossover trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Rocker-soled shoes and walking distance in patients with calf claudication. [2004]

4. Italy pubmed.ncbi.nlm.nih.gov

Referral from vascular surgery to cardiovascular rehabilitation and related outcomes in patients with peripheral arterial disease: the THINKPAD-RELOADED survey. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Use of a three-curved rocker sole shoe modification to improve intermittent claudication calf pain--a pilot study. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Athletic footwear. [2004]

7. England pubmed.ncbi.nlm.nih.gov

Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. [2021]

8. England pubmed.ncbi.nlm.nih.gov

How effective is cushioned therapeutic footwear in protecting diabetic feet? A clinical study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Mechanical adaptations in walking using carbon fiber ankle foot orthoses for patients with peripheral artery disease. [2023]

10. Netherlands 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. [2023]