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).
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …