RESUMEN
The healing process in diabetic foot ulcer (DFU) is hindered by factors such as chronic inflammation, defects in fibroblast function, poor angiogenesis, and lack of cell migration. Recombinant human epidermal growth factor (rhEGF) has been shown to enhance extracellular matrix formation, cellular proliferation, and angiogenesis. Therefore, intralesional application of rhEGF in DFU could accelerate wound healing. Our objective was to determine the efficacy and safety of rhEGF in patients with DFU. A randomized, double-blinded, placebo-controlled study was conducted comparing a thrice-per-week intralesional application of rhEGF (75 µg) or placebo in patients with DFU for 8 weeks. The number of completely healed ulcers, size, and wound bed characteristics were evaluated to determine the efficacy of rhEGF. Adverse events were recorded and analyzed to establish its safety. A total of 34 patients were recruited for the study. After three dropouts, we were able to follow and analyze 16 patients in the placebo group and 15 patients in the rhEGF study to the end of the trial. Baseline testing showed that both groups were similar. Compared to the placebo group, more ulcers achieved complete healing in the rhEGF group (rhEGF, n = 4; placebo, n = 0; p = 0.033); ulcers in the rhEGF group decreased in area size (12.5 cm2 [rhEGF] vs. 5.2 cm2 [placebo]; p = 0.049); and more epithelial islands in the wound bed were present (28% vs. 3%; p = 0.025). Mild transitory dizziness was the only side effect that was more frequently noted in the rhEGF group. Our results showed that in patients with DFU who received standard care, intralesional rhEGF application resulted in complete healing in more patients, promoted the epithelialization of the wound bed, and significantly reduced the area of the DFU treated. Therefore, rhEGF resulted in better outcomes for patients suffering from DFU.
Asunto(s)
Inductores de la Angiogénesis/uso terapéutico , Pie Diabético/tratamiento farmacológico , Factor de Crecimiento Epidérmico/uso terapéutico , Cicatrización de Heridas/efectos de los fármacos , Adulto , Amputación Quirúrgica , Proliferación Celular/efectos de los fármacos , Pie Diabético/patología , Pie Diabético/fisiopatología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Tejido de Granulación/efectos de los fármacos , Humanos , Inyecciones Intralesiones , Masculino , México/epidemiología , Proteínas Recombinantes/uso terapéutico , Resultado del TratamientoRESUMEN
Pressure ulcers (PU) are the source of multiple complications and even death. To our knowledge, there is no available data about PU prevalence in Mexico. The objective of this study was to determine the point prevalence of PU in three second-level hospitals in Mexico. Every adult hospitalised patient was included in each hospital. Age, gender, hospitalisation ward, Braden score, and the number, location and stage of the ulcers encountered were recorded, as well as any pressure relief measures. In total, 294 patients were examined (127 were male); of these, 63 were considered to be at risk. The average age was 48·6 years. The overall prevalence of the PU was 17%. The service with the highest prevalence was the ICU. The most frequent stage was II (32%) and they were most commonly found in the sacrum (74%). The average Braden score of the patients with ulcers was 10, and 21·4% of the patients obtained moderate- to high-risk Braden scores. Of them, 60·3% had ulcers and only 46% had any preventive measures. The prevalence of PU in three hospitals in Mexico is 17%. The most common stage is II and the most commonly affected site is the sacrum. Only 46% of patients with PU had at least one pressure release measure.