Trial Outcomes & Findings for Improving Walking in Peripheral Artery Disease (NCT NCT05103280)

Last Updated: 2025-10-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Baseline and after three-months intervention

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Progressive Improvement in Walking Performance A total of 10 participants with peripheral artery disease were enrolled in this single-arm study. Each participant wore only one type of preferred assistive shoes-carbon-fiber insole shoes, or spring-loaded shoes-over the course of a three-month intervention period. The aim was to assess how walking performance changed within each participant following the use of assistive shoes, relative to their baseline performance.
Overall Study STARTED	10
Overall Study SL for Intervention	7
Overall Study CF for Intervention	3
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Walking in Peripheral Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 8.01 • n=5 Participants
Sex: Female, Male Progressive improvement in walking performance · Female	0 Participants n=5 Participants
Sex: Female, Male Progressive improvement in walking performance · Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after three-months intervention

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Changes in Walking Distance After Three-months Intervention Baseline	289.68 meters Standard Deviation 196.11
Changes in Walking Distance After Three-months Intervention After Three months	262.95 meters Standard Deviation 165.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants standard shoe	5.5 units on a scale Standard Deviation 1.08
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants carbon fiber	5.9 units on a scale Standard Deviation 2.3
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants spring loaded	6.6 units on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Changes in Vertical Ground Reaction Force After Three-months Intervention Baseline	769.34 Newton Standard Deviation 150.09
Changes in Vertical Ground Reaction Force After Three-months Intervention after three-months intervention	845.38 Newton Standard Deviation 118.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Changes in Muscle Oxygenation After Three-months Intervention Baseline	36.82 Muscle oxygen saturation percentage Standard Deviation 15.92
Changes in Muscle Oxygenation After Three-months Intervention After three months	40.02 Muscle oxygen saturation percentage Standard Deviation 12.30

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Changes in Physical Activity After Three-months Intervention Baseline	4099.102 steps/day Standard Deviation 4035.33
Changes in Physical Activity After Three-months Intervention After three months intervention	4740.85 steps/day Standard Deviation 4913.19

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Progressive Improvement in Walking Performance n=10 Participants 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. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
Changes in Rate of Perceived Exertion Score After Three-months Intervention Baseline	12.6 score on a scale Standard Deviation 2.7
Changes in Rate of Perceived Exertion Score After Three-months Intervention After three months	13.25 score on a scale Standard Deviation 2.3

Adverse Events

Assistive Shoe Intervention for PAD Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara A. Myers, PhD - Professor

University of Nebraska at Omaha

Phone: (402) 554-3246

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place