40 and older, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes in Walking Distance After Three-months InterventionPrimary· 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.
Baseline
Group
Value
95% CI
Progressive Improvement in Walking Performance
289.68
± 196.11
After Three months
Group
Value
95% CI
Progressive Improvement in Walking Performance
262.95
± 165.97
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by ParticipantsPrimary· 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.
standard shoe
Group
Value
95% CI
Progressive Improvement in Walking Performance
5.5
± 1.08
carbon fiber
Group
Value
95% CI
Progressive Improvement in Walking Performance
5.9
± 2.3
spring loaded
Group
Value
95% CI
Progressive Improvement in Walking Performance
6.6
± 2.06
Changes in Vertical Ground Reaction Force After Three-months InterventionSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Ground Reaction Force Improvement
769.34
± 150.09
after three-months intervention
Group
Value
95% CI
Ground Reaction Force Improvement
845.38
± 118.24
Changes in Muscle Oxygenation After Three-months InterventionSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Ground Reaction Force Improvement
36.82
± 15.92
After three months
Group
Value
95% CI
Ground Reaction Force Improvement
40.02
± 12.30
Changes in Physical Activity After Three-months InterventionSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Ground Reaction Force Improvement
4099.102
± 4035.33
After three months intervention
Group
Value
95% CI
Ground Reaction Force Improvement
4740.85
± 4913.19
Changes in Rate of Perceived Exertion Score After Three-months InterventionSecondary· Baseline and 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.
Baseline
Group
Value
95% CI
Rate of Perceived Exertion in Progressive Treadmill Test Before and After Intervention
12.6
± 2.7
After three months
Group
Value
95% CI
Rate of Perceived Exertion in Progressive Treadmill Test Before and After Intervention
13.25
± 2.3
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 31 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05103280.