ELECTROTHERAPY REVERSES INFRAMALLEOLAR ISCHEMIA

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DESCRIPTION: ( Adapted from the applicant's abstract). The applicants propose to use electrotherapy known as High Volt Pulsed Galvanic Stimulation (HVPGS) to stimulate improved blood flow to the peripheral vascular circulation for the treatment of peripheral vascular disease. HVPGS consists of direct, coupled continuous trains of pulses, each a submicrosecond doublet of high (>10 ma) peak amplitude. This signal augments microcirculation, as measured by transcutaneous oxygen (TcPO2), despite large vessel obstructive disease. For ischemic ulcers and incisions, HVPGS enhances the microcirculation transiently during treatment and slowly and persistently during the course of repeated treatments. HVPGS may produce arterial vasodilatation through a mechanism that is similar to the neuro inflammatory "wheel and flare" response. The investigators will conduct an unblinded, controlled clinical trial in a patient cohort with known chronicity and defined microvascular disease. Reperfusion of ischemic skin will be confirmed by TcPO2 oximetry and laser Doppler flow measurements. Microcirculaton improvements will be correlated with wound reduction and limb salvage rates. If outcomes are positive, electrotherapy should augment limb salvage and decrease amputation rates. PROPOSED COMMERCIAL APPLICATION: Wound care market Limb salavage market