REAL WORLD EVIDENCE STUDY
Reduced Hospitalizations and Amputations in Patients with Diabetic Foot UlcersTreated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes Jessica Izhakoff Yellin, Julia A. Gaebler, Frank F. Zhou, Timothy Niecko, Olivia Novins, Amelia Ockert, Darcy Krzynowek, Matthew G. Garoufalis, Aliza M. Lee, and Robert G. Frykberg
#1 Ranked Journal in Wound Care
RESULTS:
➤ Unmatched cohort representing the real world heterogenic mix of patients treated for DFU
➤ Matched cohort of DFU patients with balanced covariants demonstrates similar outcomes to unmatched cohort
➤ The logistic regression of matched cohorts demonstrate the odds of hospitalization and amputation when not treated with TWO2
RESEARCH DESIGN:
➤ Study was performed at two U.S. Veterans Affairs hospitals
➤ Medical records were reviewed for demographic information such as age, sex, ethnicity, wound characteristics, wound duration, Wagner classification, wound area, CVD, PVD, kidney disease, HbA1c, history of amputation, and neuropathy.
➤ The Primary Outcomes were patients requiring hospitalization and/or amputation within 360 days of initial wound documentation.
BOTH cohorts received Standard of Care (SOC) and may have received adjunct therapies including negative pressure wound therapy (NPWT), skin substitutes (SS), and/or growth factors (GF).
CONCLUSION: 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.
MULTI-MODALITY TWO2 WORKS LIKE NO OTHER
OXYGEN
High-pressure delivery results in greater tissue diffusion critical to restoring normal wound metabolism, resulting in more effective and durable healing.
COMPRESSION
Non-contact cyclical compression addresses edema and helps correct the underlying peripheral vascular disease.
HUMIDIFICATION
Assures an ideal wound healing environment, promoting healthy granulation tissues for faster, more effective and durable healing.
REFERENCES:
- National Health Interview Survey by the Centers for Disease Control and Prevention and the S. Census Bureau.
- Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Jessica Izhakoff Yellin, Julia Gaebler, Frank F. Zhou, Timothy Niecko, Olivia Novins, Amelia Ockert, Darcy Krzynowek, Matthew G. Garoufalis, Aliza M. Lee, and Robert G. Frykberg; Advances in Wound Care 2022; http://doi.org/10.1089/wound.2021.0118
- A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trialto Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study; Diabetics Care 2020;43:616-624 | https://doi.org/10.2337/dc19-0476.