Objective: To compare outcomes for Medicare patients with
diabetic foot ulcer(s) (DFU) receiving cryopreserved placental membrane containing viable cells (vCPM) to other Cellular- and Tissue-Based Products (
CTPs). Approach: Patients with DFU and
CTP use were selected in Medicare claims (2013-2017) by using a strict definition of DFU with demonstrated diabetes etiology. We compared the effectiveness of vCPM with other
CTPs on: (1) reduction of post-treatment
ulcer occurrence, and (2) reduction in 1 year mortality. We controlled for selection bias and differential risk characteristics between comparison groups in a two-stage inverse probability treatment weighting model. Results: Overall, 7,869 DFU episodes with
CTP use met inclusion criteria: 786 received vCPM, 4,546 received another "cellular"
CTP, and 2,537 received "acellular"
CTP. For
ulcer occurrence, we examined: 30-, 90-, 180-, and 365 days post-treatment. We found a significant reduction in
ulcers at each period for vCPM compared with either alternative
CTP-results range from a 36.7% percentage point reduction in
ulcer occurrence at 30 days compared with cellular
CTP, and a 58.5% percentage point reduction at 365 days compared with acellular
CTP. Further, the application of vCPM reduces mortality within 1 year by 2.3 percentage points (13-13.8% change) compared with other
CTPs. Innovation: This study examines the differences in
ulcer occurrence and mortality for Medicare DFU patients receiving vCPM and other
CTPs. Our strict DFU definition excludes beneficiaries without
foot ulcer with demonstrated diabetes etiology. Conclusion: Among
CTPs, vCPM users have reduced
ulcer rates (recurrent or new) and reduced all-cause mortality compared with other "cellular" and "acellular"
CTPs.