title: Efficacy of intralesional recombinant human epidermal growth factor in diabetic foot ulcers in Mexican patients: a randomized double-blinded controlled trial.
abstract: 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.
authors.affiliation: Interdisciplinary Wound and Ostomy Care Center, Division of Dermatology, Dr. Manuel Gea Gonzalez General Hospital, Mexico City, Mexico.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Gomez-Villa
authors.forename: Francisco
authors.initials: F
authors.lastname: Aguilar-Rebolledo
authors.forename: Adriana
authors.initials: A
authors.lastname: Lozano-Platonoff
authors.forename: Juan Miguel
authors.initials: JM
authors.lastname: Teran-Soto
authors.forename: Maria Rosy
authors.initials: MR
authors.lastname: Fabian-Victoriano
authors.forename: Nicole Stephanie
authors.initials: NS
authors.lastname: Kresch-Tronik
authors.forename: Ximena
authors.initials: X
authors.lastname: Garrido-Espíndola
authors.forename: Adriana
authors.initials: A
authors.lastname: Garcia-Solis
authors.forename: Augusto
authors.initials: A
authors.lastname: Bondani-Guasti
authors.forename: Guillermo
authors.initials: G
authors.lastname: Bierzwinsky-Sneider
authors.forename: José
authors.initials: J
authors.lastname: Contreras-Ruiz
mesh_terms: D000328:Adult; D000671:Amputation, Surgical; D043925:Angiogenesis Inducing Agents / Q000627:therapeutic use*; D049109:Cell Proliferation / Q000187:drug effects; D017719:Diabetic Foot / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000627:therapeutic use*; D005260:Female; D006097:Granulation Tissue / Q000187:drug effects; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008800:Mexico / Q000453:epidemiology; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D043925:Angiogenesis Inducing Agents; D011994:Recombinant Proteins; D004815:Epidermal Growth Factor