Real-world outcomes of a placenta-based tissue product versus standard of care for lower extremity diabetic ulcers: a Medicare cohort study

OBJECTIVE: To review data from the Centers for Medicare and Medicaid Services (CMS) database in order to compare clinical outcomes of patients who were treated with Artacent Wound and Artacent AC (Tides Medical, US), a dual-layer amniotic membrane (DLAM), with patients who received debridement alone. METHOD: A retrospective cohort study was conducted using a 1:1 matching procedure based on six pre-specified baseline covariates of Medicare patients who received DLAM or debridement alone for the treatment of lower extremity diabetic ulcers (LEDUs) between 2020 and 2023. LEDU episodes were constructed from claims data by linking sequential services until a 60-day clean period without LEDU-related claims was observed, which signified the end of an episode. Outcomes assessed within each completed episode included major and minor amputations, as well as emergency department (ED) visits, hospital readmissions, or care transitions to other sites of service, such as skilled nursing facilities. RESULTS: There were >2 million eligible episodes identified in the CMS database, of which 1244 LEDU episodes (622 in each cohort) met study eligibility and were analysed. Based on the analysis, approximately one major amputation was prevented for every 32 patients treated with DLAM as compared to debridement alone. Inpatient admissions, ED visits and skilled nursing facility visits were significantly reduced in the DLAM cohort. CONCLUSION: Medicare patients treated with DLAM experienced significantly lower rates of major amputations and reduced healthcare use compared with those treated with debridement alone. Promising results from this study may provide another advanced wound care option to add to the treatment armamentarium.