Efficacy of topical epidermal growth factor in healing diabetic foot ulcers
Background: Peripheral neuropathy, vascular disease and immune dysfunction contribute towards the pathogenesis of the diabetic foot. Given that the only growth factor approved by the US Food and Drug Administration for the treatment of diabetic foot ulcers is platelet-derived growth factor-BB, and that controversy remains regarding the role of epidermal growth factor (EGF) in the management of this disorder, we conducted a study to assess the efficacy of EGF in accelerating the healing of diabetic foot ulcers. Methods: In a single-blind, placebo-controlled clinical trial, 30 diabetic patients, (14 women and 16 men, age range: 27-77 years) were treated with topical EGF, and 20 controls (11 men, 9 women, age range: 32-75 years) were treated with placebo. Both groups were otherwise treated by wound debridement and irrigation with normal saline solution, systemic antibiotic therapy and daily wound dressing. The treatment and follow-up period was 4 weeks. Results: After 4 weeks, average wound closure in the treatment group was significantly greater than in placebo (71.2 vs. 48.9%, p = 0.03). Complete wound closure as a result of treatment was observed in seven patients and in one patient from the placebo group. EGF was significantly more effective than placebo in stimulating diabetic foot ulcer healing (relative risk: 3.4; 95% confidence interval: 1.84-13.61). Conclusions: This study demonstrates a potential effect of topical EGF in significantly speeding up wound healing in diabetic foot ulcers; however, further multicenter studies are required in the future to confirm these results in a larger population. © 2005 Future Drugs Ltd.