Objective To systematically analyze the randomized controlled trials that compare tissue-engineered skin (TES) with conventional treatment for chronic diabetic foot ulcer (DFU) in terms of effectiveness and utilization.Methods We searched the electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, CBMWeb, CNKI, and VIP) in order to compare the efficiency and safety between TES and conventional treatment (CT) in the patients with DFU. In addition, we manually searched reference lists from original studies and review articles.Results Seven trials were included, which were all randomized controlled trials and had a duration of DFU over 6 weeks. There were 880 participants that met inclusion criteria in all studies, and all patients underwent pre-treatment procedures and were treated by TES (human skin equivalents, living skin equivalents or bioengineered skin, such as Graftskin, Dermagraft and Graftjacket) for 12 weeks. All trials had two groups: the treatment group and the control group, but the two trials divided the treatment groups into 3 different dosages and 2 different ulcer allocation subgroups, respectively. Meta-analysis results showed significant differences in the rate of complete wound closure (Plt;0.0001, 95%CI 0.08 to 0.20) and in the occurrence of complications and severe adverse events (P=0.008, 95%CI – 0.06 to – 0.01) between TES treated patients and conventionally treated patients. Conclusion The review shows TES improves completed closure of DFU compared with CT, and it is more effective in reducing side effects.
