Vacuum Therapy for Intermittent Claudication: A Randomized Controlled Trial

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Introduction - Early 2015, intermittent vacuum therapy (IVT) was intensively promoted in the Netherlands as a minimally invasive treatment for intermittent claudication (IC). IVT implies that a patient is placed in a tubular device and undergoes periods of negative pressure applied to the lower body, assumed to stimulate leg circulation. A literature search revealed no evidence to substantiate claims that were made by the IVT company. Aim of this multicenter randomized controlled trial was to determine a potentially additional effect of IVT on walking distance and health-related quality of life in patients with IC. Methods - At three vascular surgery outpatient clinics, patients with symptomatic IC and a <0.90 rest ankle-brachial index (ABI) or a >0.15 ABI drop after exercise were randomized to two treatment arms. The experimental group (“IVT”) received supervised exercise therapy (SET) and IVT with a negative pressure of -50 mBar, whereas the control group (“Sham”) received SET and IVT with a negative pressure of -5 mBar. IVT was provided during twelve 30 minute sessions over a six weeks period. Patients and SET-providing physiotherapists were blinded for the given treatment. Primary outcome measure was the maximal walking distance (MWD) as measured by a standardized treadmill test. Secondary outcome measures were functional walking distance (FWD) and disease-specific quality of life (VascuQol questionnaire). Results - Seventy-eight patients were randomized (IVT, n=39; Sham, n=39; male 63%; mean age 68 ± 9 years). There were no baseline differences regarding walking distances and quality of life. MWD and FWD increased in both groups after six and 12 weeks (P<0.001). The median increase in MWD after 12 weeks was +220 m (100-430) in the IVT group versus +335 m (220-705) in the Sham group (P=0.055). The increase in FWD was +210 m (90-370) in the IVT group versus +230 m (145-391) in the Sham group (P=0.201). After 12 weeks, no significant differences in absolute walking distances between groups were found. Disease-specific quality of life also increased in both groups although significant differences between groups were again absent. Conclusion - Intermittent vacuum therapy does not confer an additional beneficial effect on walking distance and health-related quality of life in patients with IC.