Accelerated Wound Healing with a Bilayer Biodegradable Synthetic Matrix in Post-Surgical Diabetes-Related Foot Wounds: A Randomised Controlled Trial

Objective: Early case series using a synthetic bilayer biodegradable matrix (BTM) for diabetes-related neuropathic and neuroischemic foot wounds have shown encouraging outcomes. This study reports results from a single-centre randomised controlled trial evaluating its efficacy in a diabetes-related foot wound cohort. Methods: Participants with moderate-to-severe post-surgical diabetes-related foot wounds (Society of Vascular Surgery WIfI grade 3 or 4) were randomised to BTM plus usual standard of care (USOC) or USOC alone. Primary outcomes were complete wound healing and amputation rates at 12 months; secondary outcomes included time to healing, wound surface area reduction, and infection rates. (Ethics approval 2021/HRE00214, ACTRNNo. 12621001613897). Results: Between May 2022 and September 2024, 64 participants were enrolled (31 BTM + USOC, 30 USOC alone; three did not complete treatment). At 12 months, complete healing occurred in 64.5% of BTM-treated wounds versus 56.7% of USOC wounds (p = 0.53, non-significant), with no significant difference in amputation rates. Post hoc Kaplan–Meier analysis of wounds with a starting surface area greater than 10 cm2 showed significantly faster healing in the BTM group (median 219 days) versus USOC alone (312 days, log-rank p = 0.037). A multivariate Cox proportional hazards regression, adjusting for WIfI score, age and starting wound area, confirmed this effect (HR 2.67, 95% CI 1.04–6.86, p = 0.04), with large BTM-treated wounds healed approximately 2.7 times faster than USOC alone. Conclusions: In this exploratory, post hoc analysis, BTM was associated with a reduction in time to complete healing in large post-surgical diabetes-related foot wounds compared with USOC. Given the post hoc nature of this finding, confirmation in a prospectively powered trial is warranted.