Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan.

Autor:	Ohura N; Department of Plastic, Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan., Kimura C; Department of Plastic and Reconstructive Surgery, Hakodate General Central Hospital, Hakodate, Japan., Ando H; Limb Salvage Center, Kasukabe Chuo General Hospital, Kasukabe, Japan., Yuzuriha S; Department of Plastic and Reconstructive Surgery, Shinshu University School of Medicine, Matsumoto, Japan., Furukawa M; Department of Plastic Surgery, Oita Oka hospital, Oita, Japan., Higashita R; Department of Cardiovascular Surgery, Yokohama General Hospital, Yokohama, Japan., Ayabe S; Department of Plastic Surgery, Yao Tokushukai General Hospital, Yao, Japan., Tsuji Y; Department of Plastic Surgery, Shinsuma General Hospital, Kobe, Japan., Fujii M; Department of Plastic and Reconstructive Surgery, Kitaharima Medical Center, Ono, Japan., Terabe Y; Department of Plastic and Reconstructive Surgery, Tokyo Nishi Tokushukai Hospital, Akishima, Japan., Sakisaka M; Department of Plastic Surgery, Shizuoka Saiseikai General Hospital, Shizuoka, Japan., Iwashina Y; Department of Plastic, Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan., Nakanishi A; Department of Plastic and Reconstructive Surgery, Ikoma City Hospital, Ikoma, Japan., Sasaki S; Department of Vascular Surgery, Sendai Social Insurance Hospital, Sendai, Japan., Hasegawa T; Department of Dermatology and Allergology, Juntendo University Shizuoka Hospital, Izunokuni, Japan., Kawauchi T; Department of Plastic Surgery, Tomei Atsugi Hospital, Atsugi, Japan., Hisamichi K; Shimokitazawa Hospital, Tokyo, Japan.
Jazyk:	angličtina
Zdroj:	Journal of wound care [J Wound Care] 2024 Jul 02; Vol. 33 (7), pp. 484-494.
DOI:	10.12968/jowc.2023.0088
Abstrakt:	Objective: To evaluate the healing outcome of a platelet-rich plasma (PRP) gel prepared using TKKT01 (a wound care device to prepare the PRP gel) in patients with hard-to-heal diabetic foot ulcers (DFUs) and who showed an inadequate response to ≥4 weeks of standard of care (SoC). Method: This open-label, single-arm, multicentre study was conducted in 15 centres in Japan. Eligible patients received PRP gel treatment twice a week for eight weeks, followed by a final evaluation after the completion of week 8 (day 57). The primary endpoint was the percentage of patients who achieved ≥50% reduction in wound radius at the final evaluation (achievement criterion, ≥60% of patients). Secondary endpoints included: wound area and volume reduction rates; time to possible wound closure by secondary intention; time to possible wound closure using a relatively simple procedure (e.g., skin graft and suture); and safety at the final evaluation. Results: A total of 54 patients were included in the full analysis set, with 47 patients included in the per protocol set; the primary endpoint was met in 38/47 (80.9%) (95% confidence interval: 66.7-90.9%) patients who achieved ≥50% wound radius reduction at the final evaluation. High rates of wound area (72.8%) and volume (92.7%) reduction were observed at the final evaluation. The median time to possible wound closure by secondary intention and by use of a relatively simple procedure was 57 and 43 days, respectively. Complete wound closure at the final evaluation was achieved in 27 (57.4%) patients. No safety concerns were raised. Conclusion: In this study, the efficacy and safety of PRP gel treatment with TKKT01 in patients with hard-to-heal DFUs in Japan were confirmed by our findings. Declaration of Interest: This study was funded by Rohto Pharmaceutical Co., Ltd., Japan. NO has been paid a consulting fee by Rohto Pharmaceutical Co., Ltd. KH is the Chief Medical Officer of Rohto Pharmaceutical. Co., Ltd. The other authors have no conflict of interest to declare.
Databáze:	MEDLINE
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