N/A
Completed N=28
Ankle-foot Orthoses for Peripheral Artery Disease
Source: ClinicalTrials.gov NCT02280200 ↗Enrolled (actual)
28
Serious AEs
12.0%
Results posted
Jul 2019
Primary outcomePrimary: Change in WIQ Distance Subscore — 22.7; -7.2 Scale units
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WIQ Distance Subscore |
22.7; -7.2 | — |
| PRIMARY Change in WIQ Speed Subscore |
14.9; -7.5 | — |
| PRIMARY Change in WIQ Stair-Climbing Subscore |
18.9; 0 | — |
| PRIMARY Change in SF-36 PCS |
2.9; 2.1 | — |
| PRIMARY Change in SF-36 MCS |
4.3; -1.1 | — |
Eligibility Criteria
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 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 illicit 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.
Data sourced from ClinicalTrials.gov (NCT02280200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.