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, jinwoo lee

Research output: Contribution to journalArticle

8 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

Fingerprint

Diabetic Foot
Epidermal Growth Factor
Randomized Controlled Trials
Placebos
Ulcer
Wound Healing
Therapeutics
Wounds and Injuries
Intercellular Signaling Peptides and Proteins
Demography
Safety

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Park, Kwang Hwan ; Han, Seung Hwan ; Hong, Joon Pio ; Han, Seung Kyu ; Lee, Doo Hyung ; Kim, Bom Soo ; Ahn, Jae Hoon ; lee, jinwoo. / Topical epidermal growth factor spray for the treatment of chronic diabetic foot ulcers : A phase III multicenter, double-blind, randomized, placebo-controlled trial. In: Diabetes Research and Clinical Practice. 2018 ; Vol. 142. pp. 335-344.
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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.",
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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. / Park, Kwang Hwan; Han, Seung Hwan; Hong, Joon Pio; Han, Seung Kyu; Lee, Doo Hyung; Kim, Bom Soo; Ahn, Jae Hoon; lee, jinwoo.

In: Diabetes Research and Clinical Practice, Vol. 142, 01.08.2018, p. 335-344.

Research output: Contribution to journalArticle

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T1 - Topical epidermal growth factor spray for the treatment of chronic diabetic foot ulcers

T2 - A phase III multicenter, double-blind, randomized, placebo-controlled trial

AU - Park, Kwang Hwan

AU - Han, Seung Hwan

AU - Hong, Joon Pio

AU - Han, Seung Kyu

AU - Lee, Doo Hyung

AU - Kim, Bom Soo

AU - Ahn, Jae Hoon

AU - lee, jinwoo

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Y1 - 2018/8/1

N2 - 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.

AB - 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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