Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes

Abstract

Background: This study sought to examine the real-world impact of multimodality cyclical-pressure topical wound oxygen therapy (TWO2) on hospitalizations and amputations in patients with diabetic foot ulcer (DFU) compared with patients without TWO2. Methods: We conducted a retrospective review of deidentified patient medical records at 2 U.S. Veterans Affairs hospitals between January 2012 and January 2020. DFU patients were assigned to TWO2 or NO TWO2 cohorts based on their treatment records. Patients received appropriate standard of care and may have received other advanced wound treatments, including skin substitutes, negative pressure wound therapy, and growth factors. Primary study outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation. Findings: Among unmatched cohorts of 202 patients with DFU (91 TWO2, 111 NO TWO2), 6.6% and 12.1% of TWO2 patients had hospitalizations and amputations, respectively, compared with 54.1% and 41.4% of NO TWO2 patients within 360 days ( p < 0.0001, p < 0.0001), representing 88% and 71% reductions. Among propensity score-matched cohorts of 140 DFU patients (70 TWO2, 70 NO TWO2), compared with NO TWO2, 82% fewer TWO2 patients were hospitalized (7.1% vs. 40.0%, p < 0.0001) and 73% fewer TWO2 patients had amputations (8.6% vs. 31.4%, p = 0.0007). Logistic regression among matched cohorts demonstrated nearly ninefold and fivefold higher risk of hospitalization and amputation, respectively, for NO TWO2 versus TWO2. Interpretation: This retrospective cohort study demonstrates that treating patients with DFU with TWO2 is associated with significant reductions in hospitalizations and amputations in the real-world setting.

Topical oxygen therapy and singlet oxygen in wound healing: A scoping review

“…The results show that patients who received indigenous NPWT with added topical pressurised oxygen therapy achieved the highest mean wound area and depth reduction, and increased sterile cultures of infected wounds after treatment. A matched cohort study by Yellin et al 35 concluded that the control group (no TWO2) had nearly nine times higher risk of hospitalisation and five times higher risk of amputation compared with the TWO2 group.…”

“…An RCT by Moffatt et al 40 demonstrated that the use of Oxyzyme dressings resulted in decreased mean costs per patient. Although cost‐effectiveness was not one of the aims of the study, findings from a retrospective cohort study by Yellin et al 35 suggest that patients that were not treated with TWO2 had nine times higher risk of hospitalisation and five times higher risk of amputation compared to the group treated with TWO2 which would imply that TOT may lead to reduced costs as hospitalisation significantly increases associated treatment costs. More research is needed to better understand the cost implication of using TOT for the treatment of wounds.…”

Physical therapy in diabetic foot ulcer: Research progress and clinical application

“…The other method is Topical oxygen therapies (TOTs), which deliver oxygen directly to the open wound 86 . Compared with systemic HBOT, it has the advantages of strong patient compliance, small equipment footprint, and low cost 70,87,88 …”

Enhancing diabetic wound healing: advances in electrospun scaffolds from pathogenesis to therapeutic applications

“…Regulating blood glucose levels and appropriate insulin therapy have shown high efficacy in wound closure ( Veves et al, 2001 ). Other methods, such as revascularization ( Liu et al, 2019 ), hyperbaric oxygen therapy ( Raspovic et al, 2022 ), and granulocyte colony-stimulating factor ( Yellin et al, 2022 ), have also been used. However, in most cases, wound dressings create an optimal environment for open wounds, leading to better and faster wound closure ( Futrega et al, 2014 ).…”