自体富血小板血浆凝胶对难愈合糖尿病足溃疡患者的疗效：日本一项多中心研究。

IF 1.5 4区医学 Q3 DERMATOLOGY

Journal of wound care Pub Date : 2024-07-02 DOI:10.12968/jowc.2023.0088

Norihiko Ohura, Chu Kimura, Hiroshi Ando, Shunsuke Yuzuriha, Masahide Furukawa, Ryuji Higashita, Shinobu Ayabe, Yoriko Tsuji, Miki Fujii, Yuta Terabe, Masanobu Sakisaka, Yuki Iwashina, Arata Nakanishi, Shigeru Sasaki, Toshio Hasegawa, Tsukasa Kawauchi, Katsuya Hisamichi

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引用次数: 0

摘要

目的评估使用 TKKT01（一种制备血小板丰富血浆凝胶的伤口护理设备）制备的血小板丰富血浆凝胶对难以愈合的糖尿病足溃疡（DFU）患者的愈合效果：这项开放标签、单臂、多中心研究在日本的 15 个中心进行。符合条件的患者接受 PRP 凝胶治疗，每周两次，为期 8 周，第 8 周结束后（第 57 天）进行最终评估。主要终点是在最终评估时伤口半径缩小≥50%的患者比例（达到标准，≥60% 的患者）。次要终点包括：伤口面积和体积缩小率；二次意向伤口闭合的可能时间；使用相对简单的程序（如植皮和缝合）进行伤口闭合的可能时间；最终评估时的安全性：共有 54 名患者被纳入完整分析集，其中 47 名患者被纳入按方案分析集；38/47（80.9%）（95% 置信区间：66.7-90.9%）名患者在最终评估时伤口半径缩小≥50%，达到主要终点。最终评估结果显示，伤口面积（72.8%）和体积（92.7%）的缩小率都很高。通过二次意向和使用相对简单的手术方法实现伤口闭合的中位时间分别为 57 天和 43 天。在最终评估中，27 名患者（57.4%）的伤口完全闭合。没有提出任何安全问题：在这项研究中，使用 TKKT01 的 PRP 凝胶治疗日本难以愈合的 DFU 患者的有效性和安全性得到了我们研究结果的证实：本研究由日本罗东制药株式会社资助。Rohto Pharmaceutical Co., Ltd.向 NO 支付了咨询费。KH 是 Rohto Pharmaceutical.Ltd. 的首席医疗官。其他作者无利益冲突需要声明。

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

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.

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来源期刊

Journal of wound care DERMATOLOGY-

CiteScore

2.90

自引率

10.50%

发文量

215

期刊介绍： Journal of Wound Care (JWC) is the definitive wound-care journal and the leading source of up-to-date research and clinical information on everything related to tissue viability. The journal was first launched in 1992 and aimed at catering to the needs of the multidisciplinary team. Published monthly, the journal’s international audience includes nurses, doctors and researchers specialising in wound management and tissue viability, as well as generalists wishing to enhance their practice. In addition to cutting edge and state-of-the-art research and practice articles, JWC also covers topics related to wound-care management, education and novel therapies, as well as JWC cases supplements, a supplement dedicated solely to case reports and case series in wound care. All articles are rigorously peer-reviewed by a panel of international experts, comprised of clinicians, nurses and researchers. Specifically, JWC publishes: High quality evidence on all aspects of wound care, including leg ulcers, pressure ulcers, the diabetic foot, burns, surgical wounds, wound infection and more The latest developments and innovations in wound care through both preclinical and preliminary clinical trials of potential new treatments worldwide In-depth prospective studies of new treatment applications, as well as high-level research evidence on existing treatments Clinical case studies providing information on how to deal with complex wounds Comprehensive literature reviews on current concepts and practice, including cost-effectiveness Updates on the activities of wound care societies around the world.