Objective: Bioengineered skin (BS) has been shown to play an important role in the treatment of diabetic foot ulcers (DFUs). Whether BS in the therapy of DFU can improve the outcomes still remains uncertain. We performed a quantitative meta-analysis of available randomized controlled trials to determine the effectiveness and safety of BS in the treatment of patients with DFUs.
Design and methods: Comprehensive search strategies of various electronic databases were used for this study to evaluate the effectiveness and safety between BS and conventional treatment (CT) in patients with DFU, and only randomized controlled trials were adopted in our review. Search terms included 'bioengineered skin', 'tissue-engineering skin', 'human-tissue graft', 'human-skin device', 'living-skin equivalent' and 'diabetic foot', 'diabetic ulcer', 'diabetic wound'. Analysis outcomes included complete wound closure, complications, ulcer recurrence and adverse severe events (ASEs).
Results: Seven randomized controlled trials on BS vs. CT were included, and 880 participants met inclusion criteria. Pooled analysis showed a significant effectiveness and safety advantages for BS treatment compared to CT for patients with DFUs. In analysis of complications, only statistically significant difference of infection was noted. And no included trials reported ASEs related to these treatments.
Conclusions: Based on the meta-analysis, patients with DFUs may benefit from the BS because of its high effectiveness and safety and reduced risk for infections in comparison to CT.