Patients suffering from chronic diabetic foot ulcers (DFUs) have experienced at least a fourfold increase in healing over standard of care with 12 weeks of home-based topical wound oxygen (TWO2) therapy. This was studied by investigators in a sham-controlled, double-blind trials they described as “groundbreaking.”
TWO2DFU compared an active home-based topical wound oxygen treatment (HyperBox, AOTI) with an identical sham device in patients with long-standing diabetic food ulcer that couldn’t be healed after an optimal period of standard of care.
This company-funded trial was ended early after active treatment showed remarkable success in the first 73 patients, as reported by Robert G. Frykberg, DPM, MPH, Diabetic Foot Consultants, Midwestern University, Glendale, Arizona, and colleagues, in their article published online on October 16 in Diabetes Care.
Along with improvement in healing the treatment also improved quality of life, even if patients only had a partial healing response. Frykberg in a company press release said that the research emphatically demonstrates, using one of the most cyclical pressurized TWO2 therapy should be considered a front-line adjunctive treatment option for Diabetes Foot Ulcers that have failed to heal with standard care alone.
He believes that the ease of use and homecare application of this approach helps with patient compliance and has an extensive cost-saving potential as compared to other options for this kind of hard-to-heal ulcer, including hyperbaric oxygen.
David G. Armstrong, MD, PhD, professor of clinical surgery at the University of Southern California, Los Angeles when approached for comment said that studies published so far suggest that, although it has some real potential or promise, topical oxygen is not revolutionary. Nonetheless it is going to be a great adjunct to good care. There might be therapies like this that will be added on, which could create an environment for healing.