| ObjectiveStem cell therapy has been a promising strategy to promote the healing of diabetic foot skin ulcers,but its clinical efficacy is still controversial.Most of the current studies are general clinical summary and retrospective analysis,which still lack sufficient evidence-based medicine.In this study,a systematic review and meta-analysis were performed to evaluate the efficacy and safety of a randomized controlled clinical trial of stem cells in the treatment of diabetic foot skin ulcers.MethodsWe systematically searched randomized controlled trials assessing the efficacy and safety of stem cell therapy in the treatment of DFU from databases including Pub Med,Web of Science,Embase,Cochrane Library,OVID Database,CNKI and CBM published during February 2020.The primary outcomes consisted of ulcer healing rate.The second outcomes included ankle brachial index(ABI),transcutaneous oxygen tension(Tc O2),the pain score amputation,the amputation rate and adverse events.Statistical analysis was conducted via Rev Man 5.3.ResultA total of nine clinical studies including 301 patients were selected for analysis.The results of the meta-analysis showed that,compared with the control group,the stem cells groups was associated with better healing of diabetic foot skin ulcers(OR9.12;95% CI,3.82 to 21.75;P < 0.0001),and presented as higher ankle-brachial index(MD=0.16;95% CI,0.12-0.19,P <0.0001),higher transcutaneous oxygen pressure(MD=12.84;95% CI,1.62 to 24.07;P <0.001),lower pain score(MD=-1.12;95% CI,1.33-0.99;P < 0.0001),the lower rate of amputation(OR= 0.36;95% CI,0.14-0.92;P = 0.03;I2= 2%),and no adverse events were observed.ConclusionStem cells can effectively promote the healing of diabetic foot skin ulcers,and it is safe to use,worthy of clinical application and promotion.However,high quality,large sample prospective randomized controlled trials are still needed to further demonstrate the above results. |
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