Publishing Outcomes of What We Do: My Realizations Around Topical Oxygen Therapy

Dear Readers:

Recently, Noridian (a Medicare Administrative Contractor with a very wide footprint) proposed a local coverage determination (LCD). Given the scope and area of Noridian’s geographic coverage, one could ask, “local to where?” This proposed LCD (DL33797) seeks to provide coverage for patients utilizing topical oxygen therapy (TOT), including both continuously diffused oxygen (CDO) and intermittent topical oxygen therapies (ITOT). At face value, for many patients and clinicians, this is a significant improvement over our current state, which is a general lack of access to this useful therapy.

However, since we (the wound care community) have almost exclusively published studies on TOT in the treatment of diabetic foot ulcers (DFUs), the people interpreting the data and writing the LCD want to limit this therapy to patients that have DFUs. On one level, this makes sense. As an individual, who like all of you, pays significantly into the Medicare Insurance program, why wouldn’t we want to only pay for therapies that are proven to be efficacious? In many ways their (Noridian’s LCD authors) recommendations mirror the trials, arguably trials that in no way speak to TOT’s clinical or physiologic strengths. 

For me, >90% of the patients I treat with TOT do not have diabetes. Yet, I have not reviewed nor presented that data to date. I will note that our algorithm of care for limited option critical limb ischemia patients will be published in an immediately upcoming “Treating the Ischemic Wound” consensus paper. TOT (especially continuous) shows strong clinical signals for deep (Stage 3) pressure injuries. Again, a therapeutic option with only one supporting paper. 

Therefore, when I write a letter to Noridian regarding the proposed LCD, I remain dependent upon anecdotal (no matter how repeated) data. Shame on me. I may have written that:

"In addition to the current proposed recommendation for diabetic foot ulcers, I recommend that TOT be considered as an adjunct to comprehensive wound care for selected patients with nonhealing ischemic wounds and pressure ulcers. Use should follow appropriate vascular assessment and management, wound-bed preparation, infection control, pressure redistribution or offloading, nutritional optimization, and serial reassessment of objective wound response.

For ischemic wounds, TOT should not replace revascularization or other indicated vascular interventions. Rather, it should be available after all reasonable efforts to evaluate and improve perfusion have been completed or when revascularization is not feasible while the patient remains under appropriate vascular and wound care management.

Published Delphi consensus guidance supports consideration of TOT for ischemic ulcers after all efforts to revascularize the affected area. The multidisciplinary panel reached 88% agreement that TOT should be considered in this setting, and 77% agreement that ischemic ulcers are wound types likely to benefit. This reflects my experience with using TOT. I have found wounds with localized ischemia to be most responsive to TOT. 

TOT should also be considered for chronic, nonhealing pressure ulcers or injuries that have not progressed despite comprehensive care. Pressure ulcer care must first address the cause of injury: pressure redistribution, repositioning, appropriate support surfaces, nutrition, moisture and incontinence management, wound-bed preparation, treatment of infection where present, and avoidance of pressure on the affected site. The Wound Healing Society’s 2023 guidance emphasizes that pressure injuries result from soft-tissue hypoperfusion and recommends comprehensive pressure redistribution, including repositioning and appropriate support-surface selection. The TOT Delphi consensus specifically identifies offloading for pressure ulcers as part of the pre-treatment work-up, alongside perfusion assessment, bacterial-load assessment, nutrition, debridement, and edema management. Published clinical literature is limited but supportive. The most recent publication on a large population of pressure, leg, and foot ulcers shows that CDO therapy has similar outcomes across a wide variety of wound types and locations. In this study, pressure ulcers and venous leg ulcers had similar healing rates as diabetic foot ulcers (73.4%, 67.0%, and 73.2%, respectively). The healing times, as measured by Kaplan-Meier analysis, were shown to be similar among all wound types as well."

Upon the completion of writing this letter, I was forced to recognize that the strongest published evidence for topical oxygen remains in diabetic foot ulcers, but that the impact of oxygen on these physiological processes is not unique to diabetic foot ulcers.  Even while pursuing this physiologic reasoning, I had to admit data was somewhat scarce in other wound types. I was embarrassed to note that – having used topical oxygen in one format or another for the last 15 years, especially in patients with stable ischemic gangrene, and having personally delayed time to amputation, delayed time to inability to ambulate and decreased the potential morbidity of vascular interventions – I had never assessed my own outcomes, defined the algorithm, nor provided to this body of literature.

By sharing my own realizations, I would like to encourage our readers to review, assess, present, and publish your outcomes. Especially in all the patients you treat who do not have diabetes. For the many of you who do this already, please keep it up; for those who think about it, go ahead and present at your local, regional, and national meetings, and, when you can, provide this to the peer reviewed literature “stash” that serves to help your colleagues provide better care to our patients. 

1. Serena T, Andersen C, Cole W, Garoufalis M, Frykberg R, Simman R. Guidelines for the use of topical oxygen therapy in the treatment of hard-to-heal wounds based on a Delphi consensus. J Wound Care. 2022;31(3):S20-S24. doi:10.12968/jowc.2022.31.Sup3.S20

2. Lavery LA, Suludere MA, Attinger CE, et al. WHS (Wound Healing Society) guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2024;32(1):34-46. doi:10.1111/wrr.13133. Epub 2023 Dec 21.

3. Mercurio M, Lavery LA, Agarwal A, Oropallo A. Clinical efficacy of continuously diffused oxygen (CDO) therapy and cohort comparison to negative pressure wound therapy (NPWT). Oxygen. 2025;5(4):26. doi:10.3390/oxygen5040026