Evaluating the number of cellular and/or tissue-based product applications required to treat diabetic foot ulcers and venous leg ulcers in non-hospital outpatient department settings.

Abstract

Background: There is substantial literature supporting the use of cellular and/or tissue-based product (CTP) in managing Wagner grade 1 and 2 diabetic foot ulcers (DFUs) and, to a lesser extent, venous leg ulcers (VLUs). Several studies advocate CTP therapy as an effective method for promoting healing in chronic DFUs and VLUs.

Objective: To evaluate how the number of CTP applications affect healing and wound area reduction (WAR) rates of DFUs and VLUs.

Methods: A multicenter private wound care practice, electronic health record, and database were used to analyze Medicare patients receiving CTPs between January 1, 2018, and December 31, 2023. Wound treatments occurred in the nursing home, private office, and home settings, not in hospital outpatient department settings. This privately funded, non-vendor-sponsored, real-world retrospective analysis included wound closure and WAR rates after each CTP application. Analysis includes current (2024) aspects of proposed local coverage determination changes that limit the number of CTP applications to 4. A paired t test was used to compare mean wound area before CTP applications and after completing CTP applications over a 16-week period. Effect sizes were analyzed using Cohen d, and correlations between the number of CTP applications and WAR were determined using the Pearson correlation coefficient.

Results: A total of 257 wounds were reviewed for analysis, of which 123 were DFUs and 134 were VLUs. For both DFUs and VLUs, there was a significant difference in the average initial wound areas (cm2) compared with the average wound areas after the CTP application series (P < .001).

Conclusion: This comprehensive retrospective real-world analysis of Medicare patients receiving CTP therapy in conjunction with standard of care treatment of DFUs and VLUs demonstrated significant reduction in the average wound area after completing a CTP application series. The results of this study could be used as a guide for the average number of CTP applications required for the effective treatment of DFUs and VLUs.