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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

PAD Trial Summary

This trial is testing whether or not special shoes can help people with peripheral artery disease (PAD) by reducing pain and increasing physical activity. PAD is a disease that results in blocked leg arteries, which can lead to amputation. This trial will help determine if the special shoes are more beneficial than standard shoes.

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.Check my eligibility

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.See study design

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.

PAD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

PAD 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,591 Total Patients Enrolled

12 Trials studying Peripheral Arterial Disease

1,000 Patients Enrolled for Peripheral Arterial Disease

University of NebraskaOTHER

536 Previous Clinical Trials

1,143,910 Total Patients Enrolled

11 Trials studying Peripheral Arterial Disease

492 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently taking on new participants?

"Affirmative. The official clinical trials database indicates that recruitment for this trial began on October 1st 2021 and is still ongoing, with the most recent update posted November 14th 2022. Currently, only 20 more volunteers are needed from one medical centre in order to meet the study's quota."

Answered by AI

What are the desired outcomes of this medical experiment?

"This clinical trial aims to assess changes in ambulatory ability over a baseline period of time as its primary outcome. Secondary metrics, such as vertical ground reaction force during treadmill tests and minimum muscle oxygenation levels are also being monitored. Additionally, patients will be asked to complete the Walking Impairment Questionnaire which produces scores ranging from 0-100 with higher numbers indicating better health status."

Answered by AI

What is the current participation rate for this experiment?

"Affirmative, clinicaltrials.gov data indicates that this medical trial is currently accepting applicants. It was first posted on October 1st 2021 and most recently updated on November 14th 2022; the study seeks to include 20 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Walking in Peripheral Artery Disease

2021. "Improving Walking in Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05103280.

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