OCEANSIDE, Calif., Dec. 13, 2022 /PRNewswire/ — Advanced Oxygen Therapy Inc. (AOTI), the global leader in noninvasive topical oxygen wound healing solutions, announced today that the American Diabetes Association has awarded an “A” grade recommendation for utilizing adjunctive topical oxygen therapy in treating Diabetic Foot Ulcers (DFU) in their 2023 standards of care in diabetes, the preeminent Clinical Practice Guidance (CPG) in the space, which was published today online: https://diabetesjournals.org/care/issue/46/Supplement_1
The American Diabetes Association is the leading clinical authority dedicated solely to combating diabetes and its complications. Based on the latest scientific research and clinical trials, their annually updated standards of care in diabetes provides the most comprehensive and trusted evidence-based clinical guideline on the prevention, diagnosis, and treatment of diabetes and its complications.
Dr. Mike Griffiths, CEO and President of AOTI commented; “We are delighted that the ADA’s Professional Practice Committee, in its 2023 update to their standards of care in diabetes, has assessed that the now overwhelming body of clinical evidence supports awarding topical oxygen therapy a converted “A” grade recommendation as an adjunctive treatment for healing DFU.”
AOTI’s unique Topical Wound Oxygen (TWO2) therapy is unlike any other topical oxygen approach, in that it is the only device that provides a multimodality treatment, combing higher pressure oxygen delivery with non-contact cyclical compression and humidity, in a therapeutic applied by the patient at home. This patented approach has been demonstrated in numerous Randomized Controlled Trial (RCT) and Real World Evidence (RWE) studies to not only heal chronic wounds at a far higher rate, but perhaps more importantly, keep them closed longer term, thereby reducing unnecessary hospitalizations and amputations.1, 2
“The more sustainable long-term healing elicited when utilizing TWO2 therapy was highlighted in the ADA guidance, with their citing of all of the RCT and RWE studies conducted with TWO2, along with multiple recent Systematic Reviews and Meta Analyses, leading to their “A” grade recommendation ” stated Dr. Griffiths
1 Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study. Robert G. Frykberg et al, Diabetics Care 2020; 43:616-624. https://doi.org/10.2337/dc19-0476.2 Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Jessica Izhakoff Yellin, et al; Advances in Wound Care 2022; http://doi.org/10.1089/wound.2021.0118
