Topical epidermal growth factor spray for the treatment of chronic diabetic foot ulcers: A phase III multicenter, double-blind, randomized, placebo-controlled trial
DC Field | Value | Language |
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dc.contributor.author | Park, Kwang Hwan | - |
dc.contributor.author | Han, Seung Hwan | - |
dc.contributor.author | Hong, Joon Pio | - |
dc.contributor.author | Han, Seung-Kyu | - |
dc.contributor.author | Lee, Doo-Hyung | - |
dc.contributor.author | Kim, Bom Soo | - |
dc.contributor.author | Ahn, Jae Hoon | - |
dc.contributor.author | Lee, Jin Woo | - |
dc.date.accessioned | 2021-09-02T08:35:26Z | - |
dc.date.available | 2021-09-02T08:35:26Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2018-08 | - |
dc.identifier.issn | 0168-8227 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/74219 | - |
dc.description.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. (C) 2018 Elsevier B.V. All rights reserved. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER IRELAND LTD | - |
dc.subject | FACTOR-BB BECAPLERMIN | - |
dc.subject | WOUNDS | - |
dc.subject | EGF | - |
dc.subject | PROLIFERATION | - |
dc.subject | STIMULATION | - |
dc.subject | GRANULATION | - |
dc.subject | EFFICACY | - |
dc.title | Topical epidermal growth factor spray for the treatment of chronic diabetic foot ulcers: A phase III multicenter, double-blind, randomized, placebo-controlled trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Han, Seung-Kyu | - |
dc.identifier.doi | 10.1016/j.diabres.2018.06.002 | - |
dc.identifier.scopusid | 2-s2.0-85049016498 | - |
dc.identifier.wosid | 000440297500037 | - |
dc.identifier.bibliographicCitation | DIABETES RESEARCH AND CLINICAL PRACTICE, v.142, pp.335 - 344 | - |
dc.relation.isPartOf | DIABETES RESEARCH AND CLINICAL PRACTICE | - |
dc.citation.title | DIABETES RESEARCH AND CLINICAL PRACTICE | - |
dc.citation.volume | 142 | - |
dc.citation.startPage | 335 | - |
dc.citation.endPage | 344 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.relation.journalWebOfScienceCategory | Endocrinology & Metabolism | - |
dc.subject.keywordPlus | FACTOR-BB BECAPLERMIN | - |
dc.subject.keywordPlus | WOUNDS | - |
dc.subject.keywordPlus | EGF | - |
dc.subject.keywordPlus | PROLIFERATION | - |
dc.subject.keywordPlus | STIMULATION | - |
dc.subject.keywordPlus | GRANULATION | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordAuthor | Diabetic foot ulcer | - |
dc.subject.keywordAuthor | Wound healing | - |
dc.subject.keywordAuthor | Epidermal growth factor | - |
dc.subject.keywordAuthor | Hemoglobin A1c | - |
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