Kwang Hwan Park1, Seung Hwan Han1, Joon Pio Hong2, Seung-Kyu Han3, Doo-Hyung Lee4, Bom Soo Kim5, Jae Hoon Ahn6, Jin Woo Lee7. 1. Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea. 2. Department of Plastic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 3. Department of Plastic Surgery, Korea University Guro Hospital, Seoul, South Korea. 4. Department of Orthopaedic Surgery, School of Medicine, Ajou University, Suwon, South Korea. 5. Department of Orthopaedic Surgery, Inha University College of Medicine, Incheon, South Korea. 6. Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea. 7. Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: ljwos@yuhs.ac.
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.
RCT Entities:
AIMS: This study was conducted to evaluate the efficacy and safety of a novel spray-applied growth factor therapy containing recombinant humanepidermal 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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