Effects of vacusac in intermittent claudication: a controlled cross-over study.

The effect of a new physical treatment modality, Vacusac, was tested on a group of patients with stable intermittent claudication. Twenty-two patients with a median age of 65 years and a median duration of intermittent claudication of 5 years were randomized to either active or placebo treatments. Seventeen patients completed the study. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) and toe pressure index (toe systolic pressure/arm systolic pressure) were calculated. After 25 active treatments, administered over a period of 2 months, the patients allocated to this group attained a significant increase in the pain-free walking distance from 54 m (24-107 m) to 99 m (30-420 m) (P less than 0.05) and in the maximal walking distance from 99 m (36-182 m) to 185 m (68-591 m) (P less than 0.05). The patient group receiving 25 placebo treatments did not show any significant changes in either the pain-free or the maximal walking distance. This group then received 25 active treatments over a period of 2 months. This active treatment resulted in a significant increase in the pain-free walking distance from 51 m (14-100 m) to 86 m (18-1000 m) (P less than 0.05) and in the maximal walking distance from 98 m (40-199 m) to 175 m (51-1000 m) (P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes