Ankle-foot Orthoses for Peripheral Artery Disease

NCT02280200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-07-31

Study results available
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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).

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • University of Minnesota

    lead OTHER

Principal Investigators

  • Ryan J. Mays, PhD, MPH, MS · International Heart Institute of Montana Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280200 on ClinicalTrials.gov