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HomeCLINICAL TRIALS, STUDIES, DATADouble-Blind Randomized Study Evaluates Continuous Diffusion of Oxygen in Patients with Chronic...

Double-Blind Randomized Study Evaluates Continuous Diffusion of Oxygen in Patients with Chronic Wounds

September 28, 2018

EO2 Concepts announced today the publication of a randomized, double-blind, multi-center study to evaluate the company’s innovative, wearable EO2 Oxygen Delivery System (EO2 System) in patients receiving treatment for diabetic foot ulcers with Continuous Diffusion of Oxygen (CDO) therapy.

Double-blind randomized study, published in the Journal of Wound Care, is the first-of-its-kind to provide the highest quality, Level I clinical evidence for the treatment of chronic wounds. In addition, the company announced positive results from an original study published in Wound Central.

The results of the double-blind, randomized study demonstrated significant improvements in the primary outcome of complete wound closure at 12 weeks with CDO therapy over the current standard of care using a placebo device. The CDO arm performed 195% better and the time to ulcer closure was significantly shorter compared to the placebo arm. Furthermore, patients with more complex wounds were more than 3x likely to experience complete wound closure with CDO treatment versus the standard of wound care alone.

“These outstanding results demonstrate that CDO therapy with the EO2 System substantially improves the healing process in chronic wounds by providing faster, complete healing, particularly in patients with more complex wounds,” stated Mark Q. Niederauer, PhD, lead publication author and Chief Technology & Operations Officer of EO2 Concepts. “These results have the potential to change the standard of care for chronic wound management going forward.”

More than 3.6 million Americans suffer from diabetic foot ulcers and venous leg ulcers each year.1,2 The wearable EO2 System is the world’s first wound healing technology that continuously (24/7) delivers, and monitors delivery of, consistent, precise levels of pure, humidified oxygen for full wound closure. Oxygen plays a pivotal role in wound healing and CDO is one of the most safe and effective approaches in wound care today.

In addition, the company announced positive results of a 20-person study, published as a peer-reviewed research paper in Wound Central, that evaluated both the effectiveness and pain-reduction properties of the EO2 System. CDO was found to reduce pain in all subjects, and rapidly reduce pain in most subjects, with some reporting complete pain relief within hours of application. Authors conclude that the reduction in pain may improve patient compliance and curtail the overuse of medications, such as opioids, prescribed to patients with chronic wound pain.

“We are very pleased by the clinical results of these two studies, which continue to support the benefits of the EO2 System as a safe and effective therapeutic option for patients suffering from the devastating effects of unhealed wounds,” stated Joe Moffett, President of EO2 Concepts. “I look forward to building on our commercial successes in the U.S., Canada, Europe, and the Middle East and supporting physicians and patients with this effective wound healing therapy.”

The results of both studies were presented by Mark Q. Niederauer, PhD, this past month at the International Skin Integrity and Infection Conference in Las Vegas, NV.  Additional information regarding the effects of pain on wound healing have been published in EO2‘s September blog post in honor of Pain Awareness Month.


Reference

1. http://www.idf.org/about-diabetes/facts-figures
2. http://www.businesswire.com/news/home/20140912005576/en/Research-Markets-Global-Advanced-Wound-Care-Market

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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