Peripheral Artery DiseasePADNCT05103280
Improving Walking in Peripheral Artery Disease
A study testing Assistive tennis shoes in people with Peripheral Artery Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Assistive tennis shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At entry into the study, all patients must:
- be able to give written, informed consent
- demonstrate positive history of chronic claudication
- have an ankle brachial index < 0.90 at rest
- have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
Who cannot join
- Any potential subjects will be excluded if they have:
- rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV)
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
About this study
Official title: Improving Walking in Peripheral Artery Disease Using Specially Designed Assistive Shoes
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. The risk of mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within 3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of specially designed assistive shoes in patients with PAD and to determine if there are any potential benefits of using these shoes over standard shoes. These assistive shoes may enable patients to carry out desired activities of daily living with less pain and more physical activity. Increasing physical activity will decrease morbidity and mortality. If proven beneficial, the findings will lead to a novel and conservative rehabilitation protocol that directly benefits Veterans nationwide.
Read the detailed description
The long-term goal of this project is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by using specially designed assistive shoes. PAD is a manifestation of systemic atherosclerosis, producing blockages in the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed nationwide in the VA. Walking-induced muscle pain, known as intermittent claudication, is the most common PAD symptom. Claudicating patients with PAD walk slower, have reduced quality of life and lose independence in performing activities of daily living. The investigators have identified consistent deficits of the ankle plantarflexors to effectively push-off during walking. Currently, there is a critical treatment gap for patients whose disease presentation does not warrant an operative approach, but who desire to restore their functional independence and walking ability. Specially designed assistive shoes (carbon fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release energy, have been shown to promote push-off efficiency in walkers and runners. These shoes may lead to improved push-off in populations with reduced ankle push-off capacity, but this has not been tested yet. This work proposes to evaluate patient preferences in terms of using assistive shoes and whether these shoes improve walking performance in claudicating patients with PAD. The investigators hypothesize that using assistive shoes (either CF or SL, based on their preference) for three months will lead to improved walking performance in patients with PAD. The investigators also hypothesize that the subject-reported preference of assistive shoes (CF versus SL) will be positive based on comfort, fatigue, ease of walking, and feasibility at the baseline session. Two hypotheses will be tested by the following three specific aims:
Aim 1: Determine the subject-reported preference of assistive shoes at the Baseline visit.
Aim 2: Determine the progressive improvements in physical activity, quality of life, and walking distance after a three-month assistive shoe intervention.
Twenty patients with PAD will be recruited. Aim 1 will primarily focus on qualitative measurements of subjects' reported preferences to identify which assistive shoes are feasible for patients with PAD to use during the three months of intervention. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each shoe condition of Aim 1. Patients will wear the preferred assistive shoes of their choice for regular daily use for three months as a conservative intervention. Physical activity, quality of life, and walking distances will be assessed prior to the start of the intervention and after three months of intervention. Overall, the aims will demonstrate the feasibility and acceptability of assistive shoes in patients with PAD. Results will support a full clinical trial and guide necessary intervention length and potential rehabilitation recommendations.
- Conditions
- Peripheral Artery Disease
- Being tested
- Assistive tennis shoes
- Keywords
- Peripheral artery disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive tennis shoesOther
Assistive shoes include carbon-fiber and spring loaded shoes.
| Study group | Role | What they receive |
|---|---|---|
| Progressive improvement in walking performance | Experimental | 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. Receives: Other: Assistive tennis shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Walking Distance After Three-months Intervention
In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Measured: Baseline and after three-months intervention
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants
At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates "Low comfort" and 10 indicates "High comfort." During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.
Measured: Baseline
Secondary outcomes (4)
Changes in Vertical Ground Reaction Force After Three-months Intervention
In this single-arm study, investigators assessed vertical ground reaction force from a pressure-instrumented treadmill during the Gardner treadmill test while walking in their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Measured: Baseline and after three-months intervention
Changes in Muscle Oxygenation After Three-months Intervention
In this single-arm study, investigators will assess minimum muscle oxygenation during the Gardner treadmill test while wearing their normal shoes.
This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Measured: Baseline and after three-months intervention
Changes in Physical Activity After Three-months Intervention
In this single-arm study, investigators calculated the average number of steps per day as a measure of physical activity using an ActiGraph accelerometer worn by participants. All participants underwent a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on their personal preference. No control group was included. Participants wore the accelerometer for 7 days before the intervention and again for 7 days after completing the three-month intervention period.
Measured: Baseline and after three-months intervention
Changes in Rate of Perceived Exertion Score After Three-months Intervention
In this single-arm study, investigators assessed the rate of perceived exertion (RPE) immediately after the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. The RPE score ranged from 6 to 20, where 6 indicated no exertion at all and 20 indicated maximal exertion.
Measured: Baseline and after three-months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ten patients will wear assistive shoes for 3 months.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Sara A. Myers, PhD, Principal investigator, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103280
- Sponsor's protocol ID
- F3877-P
- Other IDs
- I21RX003877
- Acronym
- PAD
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2021
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created for sharing purposes. All the outcomes and results will be published in peer-reviewed journals and conference proceedings. The raw data will be shared in a de identified, anonymized dataset upon request with a written agreement from recipient. Therefore, the recipient will be able to complete follow-up and perform new analyses of the raw data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Walking in Peripheral Artery Disease Using Specially Designed Assistive Shoes
- ClinicalTrials.gov ID
- NCT05103280
- Acronym / sponsor ID
- PAD / F3877-P
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Nebraska
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. The risk of mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within 3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of specially designed assistive shoes in patients with PAD and to determine if there are any potential benefits of using these shoes over standard shoes. These assistive shoes may enable patients to carry out desired activities of daily living with less pain and more physical activity. Increasing physical activity will decrease morbidity and mortality. If proven beneficial, the findings will lead to a novel and conservative rehabilitation protocol that directly benefits Veterans nationwide.
Detailed description
The long-term goal of this project is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by using specially designed assistive shoes. PAD is a manifestation of systemic atherosclerosis, producing blockages in the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed nationwide in the VA. Walking-induced muscle pain, known as intermittent claudication, is the most common PAD symptom. Claudicating patients with PAD walk slower, have reduced quality of life and lose independence in performing activities of daily living. The investigators have identified consistent deficits of the ankle plantarflexors to effectively push-off during walking. Currently, there is a critical treatment gap for patients whose disease presentation does not warrant an operative approach, but who desire to restore their functional independence and walking ability. Specially designed assistive shoes (carbon fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release energy, have been shown to promote push-off efficiency in walkers and runners. These shoes may lead to improved push-off in populations with reduced ankle push-off capacity, but this has not been tested yet. This work proposes to evaluate patient preferences in terms of using assistive shoes and whether these shoes improve walking performance in claudicating patients with PAD. The investigators hypothesize that using assistive shoes (either CF or SL, based on their preference) for three months will lead to improved walking performance in patients with PAD. The investigators also hypothesize that the subject-reported preference of assistive shoes (CF versus SL) will be positive based on comfort, fatigue, ease of walking, and feasibility at the baseline session. Two hypotheses will be tested by the following three specific aims:
Aim 1: Determine the subject-reported preference of assistive shoes at the Baseline visit.
Aim 2: Determine the progressive improvements in physical activity, quality of life, and walking distance after a three-month assistive shoe intervention.
Twenty patients with PAD will be recruited. Aim 1 will primarily focus on qualitative measurements of subjects' reported preferences to identify which assistive shoes are feasible for patients with PAD to use during the three months of intervention. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each shoe condition of Aim 1. Patients will wear the preferred assistive shoes of their choice for regular daily use for three months as a conservative intervention. Physical activity, quality of life, and walking distances will be assessed prior to the start of the intervention and after three months of intervention. Overall, the aims will demonstrate the feasibility and acceptability of assistive shoes in patients with PAD. Results will support a full clinical trial and guide necessary intervention length and potential rehabilitation recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ten patients will wear assistive shoes for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Progressive improvement in walking performance | Experimental | Other: Assistive tennis shoesA 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 may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be able to give written, informed consent
- demonstrate positive history of chronic claudication
- have an ankle brachial index < 0.90 at rest
- have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks
Key exclusion criteria (4 listed)
- rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV)
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assistive tennis shoesAssistive shoes include carbon-fiber and spring loaded shoes. | Other | Progressive improvement in walking performance |
Primary outcome
Changes in Walking Distance After Three-months Intervention
Time frame: Baseline and after three-months intervention
In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants
Time frame: Baseline
At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates "Low comfort" and 10 indicates "High comfort." During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.
4 secondary outcomes
Changes in Vertical Ground Reaction Force After Three-months Intervention
Time frame: Baseline and after three-months intervention
Changes in Muscle Oxygenation After Three-months Intervention
Time frame: Baseline and after three-months intervention
Changes in Physical Activity After Three-months Intervention
Time frame: Baseline and after three-months intervention
Changes in Rate of Perceived Exertion Score After Three-months Intervention
Time frame: Baseline and after three-months intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created for sharing purposes. All the outcomes and results will be published in peer-reviewed journals and conference proceedings. The raw data will be shared in a de identified, anonymized dataset upon request with a written agreement from recipient. Therefore, the recipient will be able to complete follow-up and perform new analyses of the raw data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara A. Myers, PhD principal investigator
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive tennis shoes in people with Peripheral Artery Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Walking Distance After Three-months Intervention (time frame: Baseline and after three-months intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.