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Comparative Effectiveness for Medicare Beneficiaries with Diabetic Foot Ulcers (DFUs) Treated with and Without Advanced Skin Substitute Products

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Wound Management & Prevention or HMP Global, their employees, and affiliates. 

Diabetic foot ulcers (DFUs) affect nearly 13% of US patients with diabetes1 and are a costly complication, contributing to substantial morbidity and mortality. To avoid limb amputation and other complications, effective interventions are crucial. There is a wide range of treatment options, including advanced skin substitutes, collagen dressings, and skin grafts, in addition to wound debridement, negative pressure wound therapy, hyperbaric oxygen therapy, offloading, and compression. But with so many options available, providers need real-world data to understand realistic clinical and economical outcomes for DFU patients.

In order to better understand which patient populations typically do and do not receive skin substitutes for DFUs and to compare rates of amputation and other DFU-related medical events among patients who do and do not receive skin substitutes, particularly among Medicare beneficiaries, researchers presented their findings in a poster this week at the Symposium on Advanced Wound Care Fall 2023 in Las Vegas, NV. Authors include Urvi Desai, PhD; J. Bradford Rice, PhD; Jian-Yu E, ScD; Serena Kongara, MPH; Justin Chun, MHS; and Robert S. Kirsner, MD, PhD.

In this study, researchers reviewed administrative claims for Medicare beneficiaries with DFUs between 2015 and 2021, matching patients who received skin substitutes 1-to-1 with those who did not using an algorithm that accounted for baseline differences in patient populations. These patient groups were then compared for rates of amputation (lower limb, above-knee, below-knew, and foot/ankle), and both all-cause and DFU-related medical events, such as hospital and outpatient visits, over the course of 6 months. While patients receiving skin substitutes had more outpatient visits (both all-cause and DFU-related), home health visits, and DFU-related podiatry visits during this period, they had equal emergency department visits and lower rates of inpatient and skilled nursing facility days than those patients who did not receive skin substitutes. Those treated with skin substitutes also had lower rates of amputations at all levels.

While this study was limited to fee-for-service Medicare beneficiaries aged 65 or older, the findings are significant. Specifically, the results illustrate that while skin substitutes are used disproportionately more among patients with more severe DFUs, those patients also saw improved outcomes over 6 months compared with patients who did not receive skin substitutes suggesting this treatment option may be effective in conserving resources and promoting positive outcomes for DFU patients.

 

References: 1Zhang P et al. Ann Med. 2017;49(2):106-116.

Poster Reference: Desai U, Rice JB, Jian-Yu E, Kongara S, Chun J, Kirsner RS. Comparative Effectiveness for Medicare Beneficiaries with Diabetic Foot Ulcers (DFUs) Treated with and Without Advanced Skin Substitute Products. Poster presented at: SAWC Fall 2023, November 2-5, Las Vegas, NV.

Acknowledgements and Financial Disclosures: Research funding provided by Organogenesis, Inc. Dr. Kirsner serves as a scientific adviser for Organogenesis.