What is the mechanism of action of this treatment?

Peripheral Arterial Disease (PAD) treatments focus on improving blood flow and reducing pain to enhance physical activity. Exercise therapy, especially supervised walking programs, is essential as it promotes vascular health and increases blood flow to the legs. Assistive devices, such as specially designed shoes, support this by reducing pain and encouraging more physical activity. This combination helps improve circulation, reduce claudication symptoms, and enhance the overall quality of life for PAD patients.

What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise therapy, pharmacologic therapy (such as cilostazol and statins), and revascularization procedures. Supervised exercise therapy is generally safe with minimal side effects, though some patients may experience muscle soreness or fatigue. Pharmacologic treatments can have side effects such as headaches, diarrhea, and palpitations (cilostazol) or muscle pain and liver enzyme abnormalities (statins). Revascularization procedures carry risks of infection, bleeding, and complications related to anesthesia. Assistive devices like specially designed shoes aim to enhance physical activity and reduce pain with minimal side effects, primarily focusing on improving mobility and comfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD) that aim to improve blood flow and enhance physical activity. Pharmacologic therapies such as cilostazol and pentoxifylline are commonly used to treat intermittent claudication, a symptom of PAD, by improving walking distance and reducing pain. Additionally, supervised exercise therapy has been recognized for its benefits in increasing physical activity levels and improving cardiovascular health in PAD patients. While specific devices like the specially designed assistive shoes are still under investigation, the focus remains on non-invasive methods to enhance mobility and reduce symptoms.

What other types of research exist?

Promising alternatives to specially designed assistive shoes for PAD patients include: 1) Wheeled Knee Walkers (WKW), which reduce plantar loading and improve ankle range of motion and locomotion speed, and 2) Supervised Exercise Therapy, which has shown long-term effectiveness in improving walking ability and reducing symptoms of intermittent claudication.

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Special Shoes for Peripheral Arterial Disease (PAD Trial)

N/A

Waitlist Available

Led By Hafizur Rahman, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and after three-months intervention

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves using specially designed shoes rather than medication, typical drug side effects are not expected. However, participants may experience discomfort or skin irritation specific to the fit and design of the assistive shoes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and after three-months intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and after three-months intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after three-months intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in walking distance after three-months intervention

Comfort level of wearing assistive shoe expressed as a numeric value and this value will be rated by participants

Secondary study objectives

Changes in Walking Impairment Questionnaire score after three-months intervention

Changes in muscle oxygenation after three-months intervention

Changes in physical activity after three-months intervention

+1 more

Trial Design

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral Arterial Disease (PAD) treatments focus on improving blood flow and reducing pain to enhance physical activity. Exercise therapy, especially supervised walking programs, is essential as it promotes vascular health and increases blood flow to the legs. Assistive devices, such as specially designed shoes, support this by reducing pain and encouraging more physical activity. This combination helps improve circulation, reduce claudication symptoms, and enhance the overall quality of life for PAD patients.

Exercise rehabilitation for patients with peripheral arterial disease.Effect of high-pain versus low-pain structured exercise on walking ability in people with intermittent claudication: meta-analysis.[Short and medium term functional capacity after single cycle of controlled physical training in subjects with claudication].

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,647 Previous Clinical Trials

3,360,058 Total Patients Enrolled

13 Trials studying Peripheral Arterial Disease

1,446 Patients Enrolled for Peripheral Arterial Disease

University of NebraskaOTHER

554 Previous Clinical Trials

1,145,424 Total Patients Enrolled

14 Trials studying Peripheral Arterial Disease

591 Patients Enrolled for Peripheral Arterial Disease

Hafizur Rahman, PhDPrincipal InvestigatorOmaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Media Library

Assistive tennis shoes Clinical Trial Eligibility Overview. Trial Name: NCT05103280 — N/A

Peripheral Arterial Disease Research Study Groups: Progressive improvement in walking performance

Peripheral Arterial Disease Clinical Trial 2023: Assistive tennis shoes Highlights & Side Effects. Trial Name: NCT05103280 — N/A

Assistive tennis shoes 2023 Treatment Timeline for Medical Study. Trial Name: NCT05103280 — N/A

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