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: Ramiro Gomez-Villa, Francisco Aguilar-Rebolledo, Adriana Lozano-Platonoff, Juan Miguel Teran-Soto, Maria Rosy Fabian-Victoriano, Nicole Stephanie Kresch-Tronik, Ximena Garrido-Espíndola, Adriana Garcia-Solis, Augusto Bondani-Guasti, Guillermo Bierzwinsky-Sneider, José Contreras-Ruiz
• Journal: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society (Wound Repair Regen) 2014 Jul-Aug Vol. 22 Issue 4 Pg. 497-503 ISSN: 1524-475X [Electronic] United States
• PMID: 25041620 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 by the Wound Healing Society.

Chemical References

• Angiogenesis Inducing Agents
• Recombinant Proteins
• Epidermal Growth Factor

Topics

• Adult
• Amputation, Surgical
• Angiogenesis Inducing Agents (therapeutic use)
• Cell Proliferation (drug effects)
• Diabetic Foot (drug therapy, pathology, physiopathology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Epidermal Growth Factor (therapeutic use)
• Female
• Granulation Tissue (drug effects)
• Humans
• Injections, Intralesional
• Male
• Mexico (epidemiology)
• Recombinant Proteins (therapeutic use)
• Treatment Outcome
• Wound Healing (drug effects)