Topical epidermal growth factor spray for the treatment of chronic diabetic foot ulcers: A phase III multicenter, double-blind, randomized, placebo-controlled trial

Kwang Hwan Park, Seung Hwan Han, Joon Pio Hong, Seung-Kyu Han, Doo Hyung Lee, Bom Soo Kim, Jae Hoon Ahn, Jin Woo Lee

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Aims: This study was conducted to evaluate the efficacy and safety of a novel spray-applied growth factor therapy containing recombinant human epidermal growth factor (rhEGF) for the treatment of chronic diabetic foot ulcers (DFU). Methods: This study was a phase III double-blind, randomized, placebo-controlled trial. 167 adult patients at six medical centers were randomized to receive routine wound care plus either topical spray treatment with 0.005% rhEGF (n = 82) or an equivalent volume of saline spray (n = 85) twice a day until ulcer healing or for up to 12 weeks. Results: Demographics, medical status, and wound characteristics were comparable between rhEGF and placebo groups. More patients in the rhEGF group significantly had complete wound healing compared to placebo (73.2% versus 50.6%, respectively; P =.001). Wound healing velocity was faster in the rhEGF group (P =.029) regardless of HbA1c levels. The rhEGF group had a shorter median time to 50% ulcer size reduction (21 versus 35 days; hazard ratio = 3.13, P <.001) and shorter time to complete ulcer healing (56 versus 84 days; hazard ratio = 2.13, P <.001). Conclusions: This study confirms that application of spray-applied rhEGF in DFU patients results in faster healing velocity and higher complete healing rate regardless of HbA1c levels.

Original languageEnglish
Pages (from-to)335-344
Number of pages10
JournalDiabetes Research and Clinical Practice
Volume142
DOIs
Publication statusPublished - 2018 Aug 1

Keywords

  • Diabetic foot ulcer
  • Epidermal growth factor
  • Hemoglobin A1c
  • Wound healing

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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