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

9 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

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, Jin Woo. / 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, Jin Woo.

In: Diabetes Research and Clinical Practice, Vol. 142, 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, Jin Woo

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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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