Subjects. Forty-four people were evaluated for
the study. All patients had disabling intermittent
claudication, defined as of a severity sufficient to
interfere with the ability of the patient to perform
social, recreational, or vocational activities. Claudication
was the limiting symptom during daily activities
and during treadmill exercise in the laboratory.
Claudication symptoms were stable over a 3-month
period before enrollment (change less than one block
in walking distance by history). Peripheral arterial
disease was confirmed by an ankle/arm systolic blood
pressure ratio of less than 0.94 at rest that decreased
to less than 0.73 after exercise. 17 The study was
approved by the University of Colorado School of
Medicine Human Subjects Committee, and informed
consent was obtained from all enrolled
subjects.