AOTI Inc. today announced that a state-of-the-art Randomized Controlled Trial (RCT) demonstrating the efficacy of its unique multi-modality cyclical pressure Topical Wound Oxygen (TWO2) therapy in healing and reducing recurrence of Diabetic Foot Ulcers (DFU) has been published online ahead of print in Diabetes Care (2019;42:1–9), the leading multi-disciplinary peer reviewed journal for health care practitioners published by the American Diabetes Association (ADA). The study can be viewed online utilizing the following link: https://care.diabetesjournals.org/lookup/doi/10.2337/DC19-0476
The authors of this breakthrough study, entitled: “A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study”, concluded that:
“This sham-controlled, double-blind RCT demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.”
In fact, the authors calculated that after adjusting for ulcer severity, Diabetic Foot Ulcers were six-times more likely to completely heal within 12 weeks and six-times more likely to remain healed after 12 months when treated with adjunctive TWO2 therapy, compared to those treated with optimal Standard-of-Care alone.
The Chief Principle Investigator of the study, Dr. Robert Frykberg, commented “the investigators could not be prouder to have participated in this groundbreaking study that emphatically demonstrates, utilizing one of the most robust protocols ever developed for the wound care space, that cyclical pressurized TWO2 therapy should be considered a front-line adjunctive treatment option for DFUs that have failed to heal with standard care alone.”
He further stated “the ease of use and homecare application of this approach are additional benefits that aid both patient compliance and offer enormous cost saving potential when compared to existing facility based Full Body Hyperbaric Oxygen (HBO) and other adjunctive treatment options.”
The robustness of the TWO2 study protocol was highlighted in a 2017 decision memorandum by the Centers for Medicare and Medicaid Services (CMS) as an example of the level of evidence and study design that they would like to see to help demonstrate efficacy for future coverage determinations.
“We are delighted that the day-to-day durable healing outcomes we have seen in treating thousands of diabetic foot ulcer patients to date across the USA and internationally have now been scientifically proven such that they were deemed publishable in such a prestigious high impact factor journal”Dr. Mike Griffiths, President and Chief Executive Officer of AOTI Inc.