Curative Metatarsal Bone Surgery Combined with Intralesional Administration of Recombinant Human Epidermal Growth Factor in Diabetic Neuropathic Ulceration of the Forefoot: A Prospective, Open, Uncontrolled, Nonrandomized, Observational Study.

backgroundCurative surgery is performed for a foot with ulcers and loss of protective sensation to heal the wound and prevent amputation. Evidence supports that patients with diabetes have decreased concentrations of growth factors in their tissues, notably epidermal growth factor (EGF). Injecting EGF deep into the bottom of the wound and its contours encourages a more effective response in terms of granulation tissue growth and wound closure.

objectiveTo assess the effectiveness and safety of curative metatarsal bone surgery combined with intralesional administration of human recombitant EGF in neuropathic diabetic forefoot ulceration.

methodsA prospective, open-label study of the effectiveness and safety of curative metatarsal bone surgery combined with intralesional administration of human recombitant EGF in neuropathic ulceration of the forefoot in patients with diabetes was conducted on a convenience sample of 212 patients with diabetes who had a total of 231 neuropathic ulcerations of the forefoot. The eligibility criteria included normal physical activity without a history of minor amputation and meeting the inclusion criteria without meeting any of the exclusion criteria in the Vascular Surgery Service of the Clinic Surgical Hospital "José R. López Tabrane" from January 2009 to May 2015. The follow-up process ended in November 2015, which was based on nonprobability consecutive sampling of 128 patients with diabetes who had a total of 131 foot ulcers in the treatment group and 84 patients with diabetes who had a total of 100 foot ulcers in the control group.

resultsThe groups had comparable demographic and baseline characteristics. In the recombitant human EGF study group, there was a 2.1-fold shorter time of re-epithelization (healing), less recidivism, and a 2.3-fold decrease in lesions, which favored the selected treatment. The safety profile was appropriate according to the low frequency of complications and the light or moderate characteristics of the complications. Only shivering and fever were more frequent in the recombitant human EGF-treated group.

conclusionsThe combination of curative metatarsal bone surgery with intralesional administration of recombinant human EGF resulted in a significant reduction in the re-epithelization time, recidivism, and development of new diabetic lesions. The safety profile was appropriate. However, more randomized, triple-blind, and placebo trials are needed to evaluate the efficacy and safety of this new therapy.