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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 
 Diabetes Research and Clinical Practice, Vol.142 : 335-344, 2018 
Journal Title
 Diabetes Research and Clinical Practice 
Issue Date
Administration, Topical ; Adult ; Aged ; Diabetic Foot/drug therapy* ; Double-Blind Method ; Epidermal Growth Factor/pharmacology ; Epidermal Growth Factor/therapeutic use* ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Ulcer/drug therapy* ; Wound Healing/drug effects*
Diabetic foot ulcer ; Epidermal growth factor ; Hemoglobin A1c ; Wound healing
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.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
박광환(Park, Kwang Hwan) ORCID logo https://orcid.org/0000-0002-2110-0559
이진우(Lee, Jin Woo) ORCID logo https://orcid.org/0000-0002-0293-9017
한승환(Han, Seung Hwan) ORCID logo https://orcid.org/0000-0002-7975-6067
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