OCEANSIDE, Calif., May 15, 2023 /PRNewswire/ — AOTI Inc, the global leader in multi-modality topical wound oxygen, announced exciting news from the 9th International Symposium on the Diabetic Foot (ISDF). The ISDF is often referred to as the Olympics of the Diabetic Foot, due to being held only every 4 years and the high quality of the clinical sessions.
The International Working Group on the Diabetic Foot (IWGDF) unveiled its 2023 Guidelines on Interventions to Enhance Healing of Foot Ulcers in People with Diabetes:
https://iwgdfguidelines.org/guidelines-2023/. In these newly released guidelines, topical oxygen therapy was awarded a positive adjunctive treatment recommendation, consistent with the “A” grade recommendation previously awarded by the American Diabetes Association (ADA) in their Standards of Care in Diabetes 2023: https://diabetesjournals.org/care/issue/46/Supplement_1.
The mission of the International Working Group on the Diabetic Foot (IWGDF) is to produce evidence-based guidelines to inform health care providers all over the world on strategies for the prevention and management of diabetic foot disease, thereby helping to reduce the high patient and societal burden of diabetic foot disease.
Additionally, AOTI’s pivotal Diabetic Foot Ulcer (DFU) study, entitled “A 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” 1 was highlighted in a dedicated session as one of the Top 4 studies of the last 4 years.
Dr. Mike Griffiths, CEO and President of AOTI commented; “We are thrilled to see the IWGDF follow the lead of the ADA in recognizing the overwhelming body of clinical evidence now supporting topical oxygen therapy in healing DFUs. We are also honored that our groundbreaking RCT that uniquely demonstrated both 12-week and 12-month healing efficacy, received such an accolade from the expert panel of the ISDF“.
AOTI’s unique Topical Wound Oxygen (TWO2) therapy is unlike any other topical oxygen approach, in that it provides a multimodality treatment, combining higher pressure oxygen delivery with non-contact cyclical compression and humidity, applied by the patient at home. This patented approach has been demonstrated in Randomized Controlled Trial and Real World Evidence studies to not only heal chronic wounds at a far higher rate, but perhaps more importantly, keep them closed longer term, thereby significantly reducing unnecessary hospitalizations and amputations.1, 2
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
