Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018)

Objective: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. Method: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. Results: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. Conclusion: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs. Declaration of interest: WHT and JD are employees of MIMEDX Group, Inc. TLT serves as a consultant to MIMEDX Group, Inc. WHT, JLD and TLT have stock in MIMEDX Group, Inc. DGA, TJC, PMG, JHH, MRK, JML and JAN served on MIMEDX Group, Inc. advisory Board. PMG, MRK and JAN served on a speakers bureau. Analysis of the Medicare database was funded by MIMEDX Group, Inc.

Automated summary

The study found that using skin substitutes for the management of lower extremity diabetic ulcers was associated with significant reductions in major and minor amputations, emergency department visits, and hospital readmissions.