SLR - September 2022 - Joshua Marmol, DPM
Reference: Yellin JI, Gaebler JA, Zhou FF, Niecko T, Novins O, Ockert A, Krzynowek D, Garoufalis MG, Lee AM, Frykberg, RG. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes. Adv Wound Care (New Rochelle). 2021 Dec 6.Level of Evidence: III
Scientific Literature Review
Reviewed By: Joshua Mormol, DPM
Residency Program: The Jewish Hospital - Mercy Health Cincinnati, Ohio
Podiatric Relevance: The nationwide rate for diabetes-related minor amputations has increased by 50 percent between 2009-2015. It is estimated that the five-year mortality rate after a lower extremity amputation ranges from 46-57 percent. Furthermore, a study in 2014 estimates that diabetic foot ulcerations (DFU) cost the United States public and private payers $9-13 billion per year not include the cost of diabetes treatment. Both amputations and hospitalizations have been shown to contribute substantially to the overall cost burden of an ulcerated patient. With this growing burden, it is paramount to find an effective therapeutic modality to lower the incidences of hospitalizations and amputations. This paper evaluated the effectiveness of topical wound oxygen therapy (TWO2) for the management of DFU.
Methods: This was a retrospective cohort study reviewing patient records from January 2012 though January 2020. The data was collected from two U.S. Veterans Affairs (VA) hospitals: Jesse Brown VA and Salem VA. Two comparison groups were established. Comparison #1: patients who have received TWO2 and other adjunctive therapies including negative pressure wound therapy, skin substitutes, and/or growth factors, with those who had never received TWO2. Comparison #2: patients who only received TWO2 and no other adjunctive wound care therapies with those who received adjunctive therapy and no TWO2. The study outcomes were defined as patients with one or more wound-related hospitalizations or amputation within 90, 180, or 360 days after first documentation of the wound.
Results: Two hundred two (202) patients with diabetic foot ulcers were identified for this study. Cohort #1 had 91 patients with DFU who received TWO2 and 111 patients who never received TWO2. It was concluded from this cohort that patients receiving TWO2 lowered hospitalizations by 88 percent and amputations by 71 percent. Furthermore, Cohort #2 had 58 patients who received only TWO2 and no other adjunctive wound care therapies, and 34 patients received only adjunctive wound care therapies and not TWO2. This cohort concluded that patients requiring hospitalizations and amputations were 82 percent and 73 percent respectively. Also, a logistic regression model within the matched cohorts demonstrates nearly a nine-fold greater risk of wound-related hospitalizations, and nearly a five-fold greater risk of amputation within 360 days of treatment in patients who did not receive TWO2 compared to those that. TWO2 demonstrated a statistically significant benefit in reducing incidence of hospitalization and amputation.
Conclusions: This study showed the real-world effectiveness of cyclical pressurized topical wound oxygen therapy in reducing wound-related hospitalizations and amputations for patients with DFU compared with patients who did not receive this intervention. The results support the use of TWO2 in the management of DFU as it stastitically improved patient outcomes and reduced cost. The value of TWO2 is clearly demonstrated and warrants close consideration for a foundational role in the treatment of DFU. Another advantage to TWO2 is the accessibility for patients. TWO2 is self-administer at the patients own home and does not require frequent visits to a specialized unit.