Ankle-foot Orthoses for Peripheral Artery Disease
Completed · Not applicable
Conditions studied: Peripheral Artery Disease
In brief
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).
Key facts
- Study ID
- NCT02280200
- Run by
- University of Minnesota
- People needed
- 31
- Starts
- 2014-11-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-07-31
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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.
Where it is running
- International Heart Institute of Montana Foundation — Missoula, Montana, United States
Full record on ClinicalTrials.gov
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