Real World Data Comparative Effectiveness of a Bilayered Living Cellular Construct and a Fetal Bovine Collagen Matrix for use in Diabetic Foot Ulcers

Introduction: Real-world data (RWD) were used to conduct a comparative effectiveness research study (CER) of a Bilayered Living Cellular Construct (BLCC)(a) versus a Fetal Bovine Collagen Matrix (FBCM; Primatrix; Integra, NJ)(b) for the treatment of diabetic foot ulcers (DFUs).Methods:Electronic medical records (WoundExpert, Net Health®, PA)(c) were collected between 2019 and 2023 on 4,362 patients (4,114 BLCC-treated, and 248 FBCM-treated) with DFUs.  Ulcers 1-20 cm2 were included. Patients with no baseline wound measurements or follow-up visits were excluded. Analyses were performed on 8,067 DFUs, 7,608 BLCC- and 459 FBCM- treated. A Kaplan-Meier (KM) analysis was used to determine frequency of healing and median time to healing. A Cox analysis that adjusted for multiple factors and covariates including area and duration was used to determine the Hazard Ratio (HR) to evaluate the probability of healing throughout the study.Results:Patient populations were comparable for demographics, wound and treatment characteristics. The median time to healing was 12 weeks for BLCC and 17 weeks for FBCM. BLCC reduced the time to healing by 29% when compared to FBCM; p=0.0003. The frequency of healing for BLCC was significantly greater compared to FBCM at week 4 (24 vs 18%), 8 (41 vs 34%), 16 (59 vs 50%), 24 (68 vs 57%), and 36 (75 vs 66%); p=0.0003. The HR = 1.29 [95% CI (1.12, 1.49)]; p=0.0004. Treating DFUs with BLCC resulted in a 29% greater probability of healing compared to FBCM.Discussion: Use of BLCC for the treatment of DFUs increased the probability and frequency of healing and decreased the time to healing when compared to FBCM. These real-word data suggest meaningful clinical benefits with BLCC treatment of DFUs1,2.References:1. Veves A, Falanga V, Armstrong DG, Sabolinski ML, Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care [Internet]. 24(2), 290–5 (2001). Available from: http://www.ncbi.nlm.nih.gov/pubmed/11213881. 2. Rice JB, Desai U, Ristovska L, et al. Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers. J. Med. Econ. [Internet]. 18(8), 586–595 (2015). Available from: http://www.ncbi.nlm.nih.gov/pubmed/25786331.