Effect of Topical Recombinant Human Epidermal Growth Factor on Wound Healing in Diabetic Foot Ulcers – A Randomized Controlled Trial

Abstract

Background: Diabetic foot ulcers (DFUs) are a serious complication of diabetes mellitus, often resulting in significant morbidity, amputations, and increased healthcare expenditures. Chronic hyperglycemia impairs the wound healing process by inhibiting cellular proliferation, growth factor responses, and angiogenesis. Topical recombinant human epidermal growth factor (hEGF) is a promising therapeutic agent that mimics the body's natural healing mechanisms by promoting epithelial cell proliferation, migration, granulation tissue formation, and re-epithelialization. Objective: To evaluate the effectiveness of topical recombinant hEGF in comparison to conventional saline dressings for the treatment of diabetic foot ulcers. Methods: This randomized controlled trial involved 80 inpatients with diabetic foot ulcers treated at the General Surgery Department of Aarupadai Veedu Medical College between November 2022 and April 2024. Patients aged between 30 and 80 years were included in the study, with exclusions for those presenting with gangrenous lesions, uncontrolled diabetes, or hypersensitivity to hEGF. Participants were divided into two groups: Group A (n=40) received normal saline dressings along with topical hEGF, while Group B (n=40) received normal saline dressings only. Ulcer sizes were measured on days 1, 7, 14, and 21, and data on granulation, wound size reduction, pus culture results, and length of hospital stay were recorded. Results: Patients in Group A demonstrated significantly smaller final wound sizes, greater reductions in wound area, and shorter hospital stays compared to Group B (p<0.05). No significant differences were observed between the two groups in terms of mean age, gender distribution, or duration of diabetes. Staphylococcus aureus was the most commonly isolated organism, followed by E. coli (26%). Conclusion: The use of topical recombinant hEGF in conjunction with normal saline dressings significantly improves wound healing in diabetic foot ulcers. This treatment approach reduces wound size, accelerates healing, and shortens hospital stays, indicating enhanced treatment efficacy and the potential for reduced healthcare costs. Incorporating hEGF into standard wound care protocols for diabetic foot ulcers could lead to better patient outcomes and increased healthcare efficiency.