Overview

This trial is active, not recruiting.

Condition peripheral artery disease
Treatment afo to improve outcomes
Sponsor International Heart Institute of Montana Foundation
Collaborator University of Montana
Start date November 2014
End date June 2017
Trial size 15 participants
Trial identifier NCT02280200, Mays-2, U54GM104944

Summary

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
open label, non-interventional design (all patients who volunteer for trial receive AFO)
afo to improve outcomes
Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.

Primary Outcomes

Measure
Difference in PWT with and without the AFO
time frame: cross-sectional (within 1 week)

Secondary Outcomes

Measure
Difference in ankle power propulsion and calf muscle recruitment with and without the AFO
time frame: cross-sectional (within 1 week)
Difference in claudication onset time with and without the AFO
time frame: cross-sectional (within 1 week)
Difference in functional ability with and without the AFO
time frame: cross-sectional (within 1 week)
Difference in peak oxygen uptake with and without the AFO
time frame: cross-sectional (within 1 week)
Change in PWT with and without the AFO
time frame: Baseline and post-12 weeks (with and without AFO at each timepoint)
Change in ankle power propulsion and calf muscle recruitment
time frame: Baseline and post-12 weeks (with and without AFO at each timepoint)
Change in claudication onset time
time frame: Baseline and post-12 weeks (with and without AFO at each timepoint)
Change in functional ability
time frame: Baseline and post-12 weeks (with and without AFO at each timepoint)
Change in peak oxygen uptake
time frame: Baseline and post-12 weeks (with and without AFO at each timepoint)
Change in patient-reported outcomes
time frame: Baseline and post-12 weeks
Change in calf and quadriceps circumference
time frame: Baseline and post-12 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD). - Patients who experience calf claudication - ≥40 years of age - An abnormal ankle-brachial index (ABI) of ≤.90. - For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI Exclusion Criteria: - Lower extremity amputation(s) which interfere(s) with walking. - Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities). - Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis) - Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening. - Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure. - Myocardial infarction within 3 months prior to screening. - Acute coronary syndrome symptoms diagnosed at time of screening. - Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and >1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm). - Transient ischemic attack or stroke 3 months prior to screening. - New left bundle branch block or sustained ventricular tachycardia >30 seconds during screening. - Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening. - Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening. - Individuals currently incarcerated. - Evidence of acute impairment from alcohol or other ilicit drugs. - Lack of diabetes control (glycated hemoglobin >12%) - Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men). - Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.

Additional Information

Official title Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
Principal investigator Ryan J. Mays, PhD, MPH, MS
Description The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO. Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes. We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by International Heart Institute of Montana Foundation.