DFUs – Bio Arterial

Clinical Studies Validating Efficacy of the Bio Arterial High-Pressure Intermittent Pneumatic Compression Therapy Device

  1. Effect of High-Pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option. Oscar Alvarez, PhD; Martin Wendelken, DPM; Lee Markowitz, DPM; and Christopher Comfort, MD. Wounds 2015; 27 (11) : 274-278.

    Abstract: 34 subjects with PAD or CLI experiencing claudication pain, resting pain, and ischemic lower leg/foot ulceration were randomized into two treatment groups. Group A consisted of 18 of these patients receiving treatment with the Bio Arterial High-Pressure IPC device for 60 minutes twice daily for 16 weeks. Group B consisted of 16 of these patients receiving standard of care consisting of an exercise regimen of walking for 20 minutes twice daily for 16 weeks.

    Conclusion: Two hours of high-pressure twice daily for 16 weeks significantly improved peak walking time, reduced resting pain, improved healing rates, physical function, and bodily pain versus the group receiving standard of care. There were no device related complication, allowing for long-term use. Furthermore, high-pressure offers an excellent alternative for the palliative care of patients suffering from the symptoms of PAD and CLI.

  2. The long-term arterial assist intermittent pneumatic compression generating venous flow obstruction is responsible for improvement of arterial flow in ischemic legs. Marzanna Zaleska, PhD; Waldemar Olszewski, MD and Ph D; and Jonathan Ross. Department of Applied Physiology and Polish Academy of Sciences, Warsaw, Poland. PLOS One, December 11, 2019, pages 1-17.

    Results: At pump inflation, an increase in toe arterial pressure, volume, capillary blood flow velocity, and one-minute arterial inflow test was observed. Two years of therapy showed persistence of resting limb increased toe capillary flow. Intermittent claudication distance increased by 20-120%. The toe arterial inflow dominated in calf skin and claudication distance without pain improved.

    Conclusion: The Bio Arterial High-Pressure device brought an increase in toe capillary flow, long lasting dilatation of toe capillaries and extension of painless walking distance. The crucial factor of rhythmic repeated venous outflow obstructions should be taken into account in designing effective assist devices.

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