Clinical Efficacy of Continuously Diffused Oxygen (CDO) Therapy and Cohort Comparison to Negative Pressure Wound Therapy (NPWT)

The purpose of this analysis is to report on the clinical efficacy of Continuous Diffusion of Oxygen (CDO) therapy in real-world clinical practice and compare those results to data published in controlled clinical studies. For the real-world clinical results, a Prospective Patients Database (PPD) of 764 patients treated using CDO therapy in a broad range of clinical practices across a wide range of wound types and wound locations was analyzed. The objectives included analyzing the clinical efficacy of CDO therapy across multiple wound types and anatomical locations, testing the data for robustness, and comparing the efficacy to results from controlled clinical studies for CDO and NPWT. The PPD data is also analyzed for efficacy among the sexes and by age for older patients in the Medicare population. The robustness of the PPD data is tested using various non- and semi-parametric statistical tools, including the Kaplan–Meier and Cox proportional hazard (PH) models, among others. The results show that CDO therapy is highly efficacious with an average healing success rate of 76.3% in real-world application, ranging from 71.2% to 84.1% for different wound types. The Medicare age population had an average age of 78 years old and similar healing rates to the overall population, with slightly better results for pressure ulcers in the older patient population. The PPD data proved to be extremely robust in every test method, demonstrating substantially equivalent efficacy in various wound types and locations, as well as between men and women. The PPD results for CDO compared favorably to clinical trial results for CDO and NPWT. Both clinical trial and PPD data for CDO exhibited better healing rates when compared to NPWT. Kaplan–Meier analysis shows that CDO use in clinical practice has 79.2% full closure in 112 days, as compared to NPWT, which has 43.2% full closure in the same timeframe for similar wound sizes and severity. These results demonstrate not only that CDO is highly efficacious in clinical practice, but that the efficacy is also similar across all wound types and locations in the body. CDO also compares very favorably to NPWT.