SAN ANTONIO--(BUSINESS WIRE)--The Journal of Diabetes Science and Technology has published online the results of a recently completed, double-blind study demonstrating positive outcomes for patients with chronic wounds who received continuous diffusion of oxygen (CDO) therapy using the TransCu O2® System by EO2 Concepts® (EO2).
“We were pleasantly surprised and heartened by the findings in this study,” noted Dr. David G. Armstrong, Professor of Surgery and Director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College of Medicine. “To see the significant difference in healing between the active and sham devices strongly suggests that this technology might hold a place in the toolbox for clinicians treating our highest-risk patients.”
“This study was the first of its kind, we believe,” said Dr. Mark Q. Niederauer, Chief Operating Officer for EO2. “The study design - fully-blinded with a sham (placebo) device in a prospective, parallel, randomly controlled trial - provides top-level clinical evidence of better wound closure and faster healing. It showed CDO to be much more effective than the standard-of-care moist wound therapy (MWT) for wounds deemed chronic.”
The purpose of the study was to assess the ability of continuously applying oxygen directly to chronic diabetic foot ulcers to close those wounds. A run-in period was used to ensure that only patients who had chronic wounds were enrolled in the study.
The results of this study show that CDO over a wound leads to significantly higher rates of closure, and faster time to closure, compared to the placebo control group. The outcomes are statistically significant, meaning they have been shown to be repeatable or have predictable effects that can be repeated.
Key findings of the study indicate that CDO:
- Heals more than twice as many wounds as MWT in the same amount of time (46% vs. 22%, p=0.02),
- Heals wounds significantly faster than MWT (p<0.001), and
- Works better relative to MWT as wounds become more severe (larger and more chronic) – CDO is three times more effective than MWT for wounds that pass published guidelines as being chronic (42.5% vs. 13.5%, p=0.006).
These results appear to indicate that the more a wound needs CDO therapy, the greater the apparent effect.
Previous research has shown benefits of applying oxygen topically to wounds. However, no studies have robustly assessed whether this would lead to a higher proportion of healing as compared to similarly treated people without the benefit of oxygen in a blinded fashion.
Double-Blind Clinical Trial
This study is unique in the medical device world in that it employed a sham, or placebo, device, similar to a pharmaceutical trial. This enabled double-blind comparison in which neither the patients nor the clinicians knew who received a placebo device and who received an active device. All patients received identical treatment with the TransCu O2 System, the only difference being that some patients were receiving oxygen (CDO therapy) and some patients were receiving no oxygen (standard MWT treatment through a placebo TransCu O2 device).
The study can further be termed as fully blinded, since not only were the patients and clinicians blinded, the investigators, statisticians and sponsor were also unaware of which treatment was being received. The study eliminated what is commonly referred to as the “placebo effect,” in which patients respond better to treatment because they believe they are receiving a more beneficial treatment.
Niederauer co-authored the published study results along with Dr. Joel Michalek of the University of Texas Health Science Center at San Antonio, and Armstrong, who was the lead principal investigator. Niederauer said the team looks forward to further scientific study that may confirm or build upon these data, including mechanisms of action.
About Trans O2® System
TransCu O2 is a wearable system that provides a continuous flow of humidified oxygen to a moist wound 24 hours a day. It is small, simple, and can be worn discretely, allowing for constant treatment without limiting mobility.
EO2 is a privately held, advanced wound-care technology company and the developer of a progressive, FDA-cleared Class II medical device that provides therapy to difficult-to-heal wounds. The TransCu O2 System is an electrochemical tissue oxygenation and wound monitoring system for use with OxySpur™ Oxygen Diffusion Dressings as an adjunctive therapy to continuously treat oxygen-compromised wounds. For more information, visit www.eo2.com.