Intermittent vacuum treatment with VacuMed does not improve peripheral artery disease or walking capacity in patients with intermittent claudication

Abstract

To assess distal blood pressures (BPs) in ankle and toe, walking capacity, intermittent claudication symptoms, physical activity and self-rated health after intermittent vacuum treatment (IVT) for peripheral artery disease (PAD). Forty-eight patients with PAD were randomised to either a control (C)-group with lifestyle changes or lifestyle changes in combination with VacuMed^® treatment thrice weekly for 6 weeks. Ankle and toe BPs were measured before, after 6 weeks of intervention and after 6 weeks follow-up. Walking capacity, intermittent claudication symptoms, physical activity and self-rated health (Likert scale) were also assessed. The ankle to brachial index (ABI) and BPs in the ankle and toe decreased after 6 and 12 weeks in both groups with no difference between the groups. In the legs with the lowest ABI at baseline in each patient, there were no differences regarding ABI, BPs and toe-systolic BP index between the groups after either the intervention or the follow-up period. The BPs decreased in both groups. The walking distance and the time to pain were unchanged in the IVT-group and increased in the C-group after the follow-up period, but without any significant differences between the groups. The level of objectively tested physical activity and self-rated health remained unchanged throughout the study in both the IVT- and the C-group. There were no differences between the changes of the self-rated health data during the study period between the IVT- and the C-group. VacuMed^® had no effect per se on distal blood pressures, walking capacity, intermittent claudication symptoms, physical activity and self-rated health.

Keywords:

• Blood pressure
• peripheral artery disease
• walking
• ankle–brachial index
• intermittent claudication
• vacuum therapy

Acknowledgements

Thanks to Wittcare A/S for demonstrating responsibility and having the courage lending out the machine, and offering financial support in form of an unrestricted grant to have a proper scientific test of their equipment performed in patients with lower extremity PAD. We are grateful for the engagement and work performed by the nurse and lab technicians in the Clinical Research Unit at Nordsjaellands Hospital and the commitment of the patients.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The study was supported by Aase og Ejnar Danielsens Fond and Murermester Lauritz Peter Christensen og hustru Kirsten Sigrid Christensens Fond.