PMID- 31773882 OWN - NLM STAT- MEDLINE DCOM- 20201102 LR - 20210703 IS - 1742-481X (Electronic) IS - 1742-4801 (Print) IS - 1742-4801 (Linking) VI - 17 IP - 1 DP - 2020 Feb TI - Efficacy of a povidone-iodine foam dressing (Betafoam) on diabetic foot ulcer. PG - 91-99 LID - 10.1111/iwj.13236 [doi] AB - This study aimed to assess the efficacy of a new povidone-iodine (PVP-I) foam dressing (Betafoam) vs foam dressing (Medifoam) for the management of diabetic foot ulcers. This study was conducted between March 2016 and September 2017 at 10 sites in Korea. A total of 71 patients (aged >/=19 years) with type 1/2 diabetes and early-phase diabetic foot ulcers (Wagener classification grade 1/2) were randomised to treatment with PVP-I foam dressing or foam dressing for 8 weeks. Wound healing, wound infection, patient satisfaction, and adverse events (AEs) were assessed. The PVP-I foam and foam dressing groups were comparable in the proportion of patients with complete wound healing within 8 weeks (44.4% vs 42.3%, P = .9191), mean (+/-SD) number of days to complete healing (31.00 +/- 15.07 vs 33.27 +/- 12.60 days; P = .6541), and infection rates (11.1% vs 11.4%; P = 1.0000). Median satisfaction score (scored from 0 to 10) at the final visit was also comparable between groups (10 vs 9, P = .2889). There was no significant difference in AE incidence (27.8% vs 17.1%, P = .2836), and none of the reported AEs had a causal relationship with the dressings. The results of this study suggest that PVP-I foam dressing has wound-healing efficacy comparable with foam dressing, with no notable safety concerns. This study was funded by Mundipharma Korea Ltd and registered at ClinicalTrials.gov (identifier NCT02732886). CI - (c) 2019 Medicalhelplines.com Inc and John Wiley & Sons Ltd. FAU - Gwak, Heui C AU - Gwak HC AUID- ORCID: 0000-0003-1062-0580 AD - Department of Orthopedic Surgery, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea. FAU - Han, Seung H AU - Han SH AD - Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. FAU - Lee, Jinwoo AU - Lee J AD - Department of Orthopaedic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. FAU - Park, Sejin AU - Park S AD - Department of Orthopedic Surgery, KangBuk Samsung Hospital, SungKyunKwan University School of Medicine, Seoul, South Korea. FAU - Sung, Ki-Sun AU - Sung KS AD - Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. FAU - Kim, Hak-Jun AU - Kim HJ AD - Department of Orthopedic Surgery, Korea University Guro Hospital, Seoul, South Korea. FAU - Chun, Dongil AU - Chun D AD - Department of Orthopaedic Surgery, College of Medicine, Soonchunhyang University Seoul Hospital, Seoul, South Korea. FAU - Lee, Kyungmin AU - Lee K AD - Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Kyungki, South Korea. FAU - Ahn, Jae-Hoon AU - Ahn JH AD - Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea. FAU - Kwak, Kyunghee AU - Kwak K AD - Department of Medical Affairs, Mundipharma Korea Ltd, Seoul, South Korea. FAU - Chung, Hyung-Jin AU - Chung HJ AD - Department of Orthopaedics, Inje University Sanggye Paik Hospital, Seoul, South Korea. LA - eng SI - ClinicalTrials.gov/NCT02732886 GR - -/Mundipharma Korea Ltd/ PT - Comparative Study PT - Journal Article DEP - 20191126 PL - England TA - Int Wound J JT - International wound journal JID - 101230907 RN - 85H0HZU99M (Povidone-Iodine) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - *Bandages, Hydrocolloid MH - Diabetes Complications/*drug therapy MH - Diabetic Foot/*drug therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Povidone-Iodine/*therapeutic use MH - Republic of Korea MH - Wound Healing/*drug effects/*physiology MH - Wound Infection/*drug therapy MH - Young Adult PMC - PMC7949421 OTO - NOTNLM OT - Betafoam OT - Medifoam OT - diabetic foot ulcer OT - povidone-iodine OT - wound healing COIS- K.K. is an employee of Mundipharma Korea Ltd. All other authors have no relevant relationships to disclose. EDAT- 2019/11/28 06:00 MHDA- 2020/11/03 06:00 PMCR- 2019/11/26 CRDT- 2019/11/28 06:00 PHST- 2019/06/24 00:00 [received] PHST- 2019/09/11 00:00 [revised] PHST- 2019/09/13 00:00 [accepted] PHST- 2019/11/28 06:00 [pubmed] PHST- 2020/11/03 06:00 [medline] PHST- 2019/11/28 06:00 [entrez] PHST- 2019/11/26 00:00 [pmc-release] AID - IWJ13236 [pii] AID - 10.1111/iwj.13236 [doi] PST - ppublish SO - Int Wound J. 2020 Feb;17(1):91-99. doi: 10.1111/iwj.13236. Epub 2019 Nov 26.