Abstract
Background Recombinant proteins and growth factors are emerging therapies for diabetic foot ulcers. Despite several clinical reports, there has been no comprehensive and systematic assessment of the totality of clinical evidence on the efficacy and safety of recombinant proteins and growth factors in diabetic foot ulcers. We tried to address this gap through an updated systematic review of randomized controlled trials (RCTs). Methods PubMed, the Cochrane Library, Scopus, Embase, and Google Scholar databases were searched, and RCTs on the efficacy of recombinant proteins and growth factors in the treatment of cutaneous wounds in diabetic patients were selected. The literature search and assessment were performed by two independent reviewers. Methodological quality of studies was appraised using the Jadad scale. Results We identified 26 RCTs involving diabetic patients with ulcer that evaluated the effectiveness of platelet-derived growth factor, epidermal growth factor, fibroblast growth factor, granulocyte colony-stimulating factor, vascular endothelial growth factor, erythropoietin, transforming growth factor, talactoferrin, and rusalatide acetate. The main primary outcome was complete healing though different indices were employed to define this such as wound closure, granulation tissue formation, or complete reepithelialization. Few studies had a follow-up period to report any recurrence and amputation rate. No adverse effect was reported due to the intervention. Conclusion Overall, there is a greater agreement on the effectiveness of EGF to enhance the healing of diabetic ulcers. Nevertheless, extant evidence is lacking for other agents since few trials have been conducted for most of the growth factors and available studies are heterogeneous in their methodologies.
Highlights
Wound repair is a complex and dynamic process composed of four overlapping healing phases of hemostasis, inflammation, tissue formation, and tissue remodeling [1]
platelet-derived growth factor (PDGF) stimulates the production of other growth factors such as vascular endothelial growth factor (VEGF) and transforming growth factor β (TGF-β) [5]
Full-text evaluation resulted in the further exclusion of 18 studies for not being conducted as randomized controlled trials (RCTs) (n = 12) or treating injuries other than diabetic ulcers such as pressure ulcers, venous ulcers, and burns (n = 6)
Summary
Wound repair is a complex and dynamic process composed of four overlapping healing phases of hemostasis, inflammation, tissue formation, and tissue remodeling [1]. PDGF is one of the first factors that received approval from the FDA, and its efficacy has been evaluated in randomized controlled trials (RCTs) [4] This factor acts as a mitogen and chemoattractant of regulatory cells to the wound environment [5]. There has been no comprehensive and systematic assessment of the totality of clinical evidence on the efficacy and safety of recombinant proteins and growth factors in diabetic foot ulcers. PubMed, the Cochrane Library, Scopus, Embase, and Google Scholar databases were searched, and RCTs on the efficacy of recombinant proteins and growth factors in the treatment of cutaneous wounds in diabetic patients were selected. We identified 26 RCTs involving diabetic patients with ulcer that evaluated the effectiveness of platelet-derived growth factor, epidermal growth factor, fibroblast growth factor, granulocyte colony-stimulating factor, vascular endothelial growth factor, erythropoietin, transforming growth factor, talactoferrin, and rusalatide acetate. Extant evidence is lacking for other agents since few trials have been conducted for most of the growth factors and available studies are heterogeneous in their methodologies
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