RESUMEN
BACKGROUND: Curative 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. OBJECTIVE: To assess the effectiveness and safety of curative metatarsal bone surgery combined with intralesional administration of human recombitant EGF in neuropathic diabetic forefoot ulceration. METHODS: A 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. RESULTS: The 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. CONCLUSIONS: The 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.
RESUMEN
Introducción: la cirugía curativa se realiza en un pie diabético con lesiones y pérdida de la sensación protectora para lograr su cicatrización. En la literatura disponible no se encontraron estudios prospectivos que avalen sus resultados cuando se aplica combinada con el Heberprot-P®. Objetivos: examinar los resultados de la cirugía curativa combinada con el Heberprot-P® en las úlceras neuropáticas del antepié. Métodos: se realizó un estudio de serie de casos en el Servicio Provincial de Angiología de Matanzas, en un período de tres años y cuatro meses. Se incluyeron pacientes diabéticos de ambos sexos que aportaron 123 extremidades con úlceras neuropáticas del antepié y que recibieron como tratamiento para las lesiones cirugía curativa y terapia adyuvante con Heberprot-P®. Resultados: las lesiones tratadas eran de gradación Wagner 2 (56,1 por ciento) y 3 (43,9 por ciento). La evaluación de la infección aportó el grado 1 (52,8 por ciento) y el grado 2 (47,2 por ciento). El tiempo de epitelización fue menor en los pacientes tratados con cirugía curativa combinada con Heberprot-P® en relación con los que no utilizaron este último. El comportamiento de las recidivas fue similar. Conclusiones: la combinación de la cirugía curativa y el Heberprot-P® en pacientes diabéticos con úlceras neuropáticas del antepié, reduce el tiempo de epitelización y de recidivas(AU)
Introduction: curative surgery is performed to reach healing of a diabetic foot with injures and loss of protective sensations. The available literature did not show prospective studies that supported the results attained with this surgery when applied with Heberprot-P®. Objectives: to analyze the results of the combination of curative surgery and Heberprot-P® to treat neuropathic ulcers of the forefront. Methods: a case series study was conducted in the provincial service of angiology in Matanzas for three years and four months, with the inclusion of 123 lower limbs with neuropathic wounds in the forefoot, which were treated with curative surgery and adjuvant Heberprot-P® therapy. Results: the treated wounds were classified as Wagner 2 (56.1 percent) and 3 (43.9 percent). The infection evaluation yielded grade 1 (52.8 percent) and grade 2 (47.2 percent). Time of epithelization exhibits a significant reduction in the patients treated with curative surgery and adjuvant therapy with Heberprot-P®, in comparison with those untreated cases. The behavior of relapses was similar in both cases. Conclusions: the association of curative surgery and Heberprot-P® used in diabetic patients with neuropathic wounds of the forefoot, reduces the time of epithelization and of relapses(AU)