Purpose: The purpose of this real-world evidence (RWE) cohort study was to evaluate whether utilization of Cyclical-Pressure Topical Wound Oxygen (TWO2) therapy had any impact on the incidence of Diabetic Foot Ulcer (DFU) related hospitalizations and amputations over a 12-month period in patients with hard to heal Diabetic Foot Ulcers (DFU)

Methods: 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 level and kidney disease etc.

Results: Within the unmatched cohorts of 202 DFU patients (91 TWO2, 1NO TWO2) there was an 88% reduction in hospitalizations and 71% reduction in amputations over the 12-month period for the patients treated with TWO2 therapy compared to those that did not receive TWO2 therapy. After propensity score matching was conducted, which minimizes the effects of confounding by achieving more balanced covariates in the absence of a randomized study, resulting in matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2) , 82% fewer TWO2 patients were hospitalized) and 73% fewer TWO2 patients had amputations, compared to those who did not receive TWO2 therapy (p < 0.0001, p = 0.00 respectively) .

Conclusions: This large RWE study demonstrates that TWO2 therapy positively impacts patient’s quality-of-life and the costs associated with treating their DFU by forcing them into remission, resulting in significantly reduced rates of amputations and hospitalizations.


M.G.Garoufalis: None.

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