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Wound Healing Society DFU Treatment Guidelines

  • Recommended topical oxygen as a Level 1 treatment recommendation
  • “Topical oxygen has been shown to increase the incidence of healing and decrease the time to heal”

The American Diabetes Association (ADA) regularly publishes standards of care and has just added CDO Therapy to their 2023 Standards of Care for the treatment of diabetic foot ulcers. The ADA article cites recent high level evidence for this decision:

“Topical oxygen therapy has been studied rather vigorously in recent years, with several high-quality RCT’s and at least five systematic reviews and meta-analyses all supporting its efficacy in healing chronic DFU’s at 12 weeks.” Diabetes Care, Volume 46, p. S212, January 2023.

This evidence includes EO2’s study published in the September of 2018 issue of the Journal of Wound Care, cited by CMS as the “Gold Standard” for how studies should be designed.

The ADA Standards of Care article goes on to state:

“Importantly, topical oxygen therapy devices provide for home-based therapy rather than the need for daily visits to specialized centers.” (such as Hyperbaric Oxygen) “Very high participation with very few reported adverse events combined with improved healing rates makes this therapy another attractive option for advanced wound care.”

The physicians who have experienced the significant impact of CDO therapy, including faster healing, reduced scarring and pain, have known that this treatment should be considered the standard of care for most wound types. Having an independent, clinically oriented organization like the American Diabetes Association make the same recommendation highlights the not only the clinical efficacy, yet also the rapidly growing adoption of CDO therapy as a standard of care.

The International Working Group for the Diabetic Foot (IWGDF) has updated their Wound Healing Guidelines to include CDO as a standard of care that should be considered when treating people with diabetes-related foot ulcers.  This makes CDO one of only 7 out of 29 therapy categories that receives this designation from the IWGDF.  Of the double-blind, randomized clinical trials reviewed by the IWGDF, EO2’s Level 1A study was noted as the strongest and the only unbiased trial to demonstrate statistically significant results in favor of complete wound healing.  This further builds on recommendations from multiple organizations, including the American Diabetes Association and the Leadership in Wound Healing conference working group.

IWGDF is an international and multidisciplinary group whose mission is to create evidence-based guidelines that are produced through a rigorous, scientific process, undertaken by those with expertise in clinical science and those with experience in clinical practice from all over the world.  Every 20 seconds somewhere in the world someone loses a leg due to the complications of diabetes. After such amputations, over half of these people will die within 5 years.  CDO therapy has been shown to significantly improve healing of these wounds to full closure, which can prevent amputations.