A new multicenter study reveals that adjunctive use of topical oxygen therapy may be beneficial in the treatment of uninfected and mildly infected diabetic foot ulcerations (DFUs).
In the randomized controlled trial (RCT), recently published by the Journal of Wound Care, researchers assessed 145 patients who had Wagner grade 1 or 2 DFUs, or Infectious Diseases Society of America (IDSA) grade 1 or 2 DFUs.1 Patients in the treatment arm of the study received a combination of continuous topical oxygen therapy plus the standard of care, which included debridement, total contact casting (TCC) and appropriate moisture managing dressings, according to the study. Patients in the other treatment arm of the study received the standard of care.
At 12 weeks, researchers noted a 30 percent higher mean wound reduction in the topical oxygen therapy group (70 percent) in comparison to the standard of care group (40 percent).1 Over 44 percent of the patients treated with topical oxygen therapy healed at 12 weeks in comparison to over 28 percent of those treated with the standard of care.
“I have been using topical oxygen therapy in my wound care practice for several years and I have had some very impressive patient successes. The results of the RCT provided increased data and validity in addition to the clinical outcomes I have been tracking in my own wound care center patient population,” notes study co-author Windy Cole, DPM, CWSP, the Director of Wound Care Research at the Kent State University College of Podiatric Medicine.
While this study assessed the use of topical oxygen therapy in patients with IDSA or Wagner grade 1 and 2 DFUs, Dr. Cole suggests this modality may also have adjunctive benefit for more severe ulcerations.
“I believe that topical oxygen therapy has the potential to be a useful adjunctive therapy for this subset of patients as well but there are more variables to consider,” notes Dr. Cole. “Wagner grade 3+ wounds typically require surgical intervention, long-term antibiotic therapy and other invasive medical interventions. Additional studies would be needed to determine the utility of topical oxygen therapy in these patients.”
Dr. Cole says the reported outcomes of the current study may help facilitate improved reimbursement for the use of topical oxygen therapy in the future.
“It is our hope that the results of our study will assist in broader insurance coverage for this therapy,” adds Dr. Cole.
- Serena TE, Bullock NM, Cole W, et al. Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomized, controlled clinical trial. J Wound Care. 2021;30(Sup5):S7-14.