Abstract

The purpose of this real-word evidence (RWE) cohort study was to evaluate whether utilization of Cyclical Pressurized Topical Oxygen (TWO2) therapy had any impact on the incidence of Diabetic Foot Ulcer related hospitalizations and amputations over a 12-month period in patients with hard to heal Diabetic foot Ulcers (DFU). An IRB approved retrospective review of deidentified DFU patient medical records was conducted at 2 US Veterans Affairs Medical Centers in Illinois and Virginia, which included demographic information on wound characteristics, clinical characteristics, neuropathy, cardiovascular disease (CVD), peripheral vascular disease (PVD), pain levels and kidney disease etc. Within the unmatched cohorts of the 202 DFU patients (91 TWO2, 111 NO TWO2)there was an 88% reduction in hospitalizations and a 71% reduction in amputations over a 12-month period for the patients treated with TWO2 therapy compared to those that did not receive TWO2 therapy. Propensity score matching was conducted showing similar outcomes and a regression analysis as preformed along with a budget impact model which demonstrated significant cost saving to the payor system. This large RWE study demonstrates the TWO2 therapy positively impacts patients quality of life and the costs associated with treating their DFU by forcing them into remission, resulting in significantly reduced rates of hospitalizations, amputations and cost outlay. Disclosure M.G.Garoufalis: Consultant; Uluru, Employee; AOT Inc., Speaker's Bureau; 3M/KCI, Horizon Therapeutics plc.

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