Breakthrough Randomized Controlled Trial Demonstrating TWO2 Efficacy in Healing Diabetic Foot Ulcers unveiled at the American Diabetes Association 78th Scientific Sessions Conference

AOTI Inc. announced today that initial results from its recently concluded Randomized Controlled Trial (RCT) demonstrating the efficacy of its patented multi-modality Topical Wound Oxygen (TWO2) homecare therapy in healing Diabetic Foot Ulcers were presented as a prestigious Late Breaking Abstract this weekend at the American Diabetes Association (ADA) 78th Scientific Sessions conference in Orlando, Florida.

The ADA estimates that Diabetes costs the USA $327 billion annually with a large portion of this cost related to treating comorbidities such as Diabetic Foot Ulcers (DFU)¹. Non-healing DFU lead to increased mortality, morbidity & health economic burden as well as decreased QOL for the sufferers².

The study was conducted at seventeen Diabetic Foot Centers of Excellence spread across the USA and Europe, with a “who’s who” of expert Opinion Leaders as its investigators. The authors of the abstract highlighted the robustness of the study protocol that was of the highest scientific level ever seen in DFU studies, being not only conducted multi-center and multi-nationally, but being also double-blinded and placebo controlled. Additionally, the study protocol included the unprecedented step of a run-in of gold standard-of-care (SOC) for all subjects meeting enrollment eligibility criteria, ensuring that only those that truly failed to heal with SOC alone would be randomized into the active phase of the study.

The authors highlighted two major statistically significant results in the abstract related to the primary outcome of the study that was ulcers completely healed at 12 weeks, namely, that:

• 41.7% of TWO2 treated ulcers were completely healed compared to just 13.5% of ulcers treated with standard-of-care alone: Pearson Chi2 = 7.2707, P = 0.007.
• TWO2 showed nearly 4 times the likelihood to completely heal ulcers compared to standard-of-care alone: HR 3.88 (95% CI 1.4, 10.71), p=0.009.

“This breakthrough study unequivocally demonstrates at the highest scientific level the efficacy of Cyclical Pressure Topical Wound Oxygen Therapy in healing Diabetic Foot Ulcers” stated Dr. Robert Frykberg, the Chief Principle Investigator of the study. “We look forward to completing the follow-up phase of the study and health economic analysis so that we can submit our full paper to a leading peer reviewed journal for publication in the near future.” he added.

The full abstract 43-LB entitled: Multi-National, Multi-Center, Prospective, Randomized, Double Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers³ can be found via the following link: https://doi.org/10.2337/db18-43-LB

About AOTI
AOTI Inc. is a private company based in Oceanside, California USA and Galway, Ireland, that provides innovative solutions to resolve severe and chronic wounds worldwide. Our products reduce healthcare costs and improve the quality of life for patients with these debilitating illnesses. Our patented noninvasive Topical Wound Oxygen (TWO2) therapy is unsurpassed in fully closing Diabetic, Venous and Pressure ulcers alike.