Abstract
The intralesional injection of recombinant human epidermal growth factor (rhEGF) has been recently approved and introduced in several countries for the treatment of advanced diabetic foot ulcers (DFU), based on the results of five exploratory and one confirmatory, phase III clinical trials in 344 subjects. A significant stimulatory effect of this product on the healing process, given by development of granulation tissue and re-epithelization was shown in these trials, as well as a reduction in lesion recurrences during follow-up, and a tendency to a reduction of the risk of amputations, with an acceptable safety profile. However, products not always perform the same way in current medical practice. The present review summarizes the clinical information available from the intralesional use of rhEGF for advanced DFU and shows that in this case the postmarketing experiences in more than 2000 subjects confirm the results of the clinical trials, with 75% probability of complete granulation response, 61% healing, and a 16% absolute and 71% relative reduction of the risk of amputation. The benefit includes ischemic patients. The safety profile in current practice was satisfactory. Serious adverse events are not attributable to the treatment but to the underlying conditions of the patients. No evidence of neoplasia promotion by the growth factor has been found. The benefit-risk ratio of the procedure is favorable.
Highlights
Diabetes mellitus is a world-wide health problem with a reported prevalence in more than 170 million in people more than 20 years-old [1]
The nationwide introduction of the use of intralesional recombinant human epidermal growth factor (rhEGF) in diabetic foot ulcer (DFU) in Cuba provided the report of the first 1851 treatments applied on 1835 lesions from 1788 subjects, including pharmacovigilance information
The clinical studies of rhEGF in 344 subjects with advanced diabetic foot ulcers (Wagners grade 3 or 4, median size >20 cm2, ischemic ulcers not excluded) have shown that injected recombinant Epidermal growth factor (EGF) has the potential to promote complete granulation in more than 80%, with complete wound healing in more than 50% of subjects usually unresponsive to other treatments, one month faster than a group treated only with standard wound care
Summary
Diabetes mellitus is a world-wide health problem with a reported prevalence in more than 170 million in people more than 20 years-old [1]. A pharmacokinetics study with the usual doses (25 μg and 75 μg) was finished on 16 subjects with non-complicated DFU (Wagners 1 and 2, which correspond to University of Texas grades I or II; stage A), and a placebo-controlled dose-exploratory trial, done on noncomplicated ulcers in 35 individuals, were taken into account, only for the safety data.
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