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

被引:0
作者
Ohura, Norihiko [1 ]
Kimura, Chu [2 ]
Ando, Hiroshi [3 ]
Yuzuriha, Shunsuke [4 ]
Furukawa, Masahide [5 ]
Higashita, Ryuji [6 ]
Ayabe, Shinobu [7 ]
Tsuji, Yoriko [8 ]
Fujii, Miki [9 ]
Terabe, Yuta [10 ]
Sakisaka, Masanobu [11 ]
Iwashina, Yuki [1 ]
Nakanishi, Arata [12 ]
Sasaki, Shigeru [13 ]
Hasegawa, Toshio [14 ]
Kawauchi, Tsukasa [15 ]
Hisamichi, Katsuya [16 ]
机构
[1] Kyorin Univ, Sch Med, Dept Plast, Reconstruct Surg, Tokyo, Japan
[2] Hakodate Gen Cent Hosp, Dept Plast & Reconstruct Surg, Hakodate, Japan
[3] Kasukabe Chuo Gen Hosp, Limb Salvage Ctr, Kasukabe, Japan
[4] Shinshu Univ, Sch Med, Dept Plast & Reconstruct Surg, Matsumoto, Japan
[5] Oita Oka Hosp, Dept Plast Surg, Oita, Japan
[6] Yokohama Gen Hosp, Dept Cardiovasc Surg, Yokohama, Japan
[7] Yao Tokushukai Gen Hosp, Dept Plast Surg, Yao, Japan
[8] Shinsuma Gen Hosp, Dept Plast Surg, Kobe, Hyogo, Japan
[9] Kitaharima Med Ctr, Dept Plast & Reconstruct Surg, Ono, Japan
[10] Tokyo Nishi Tokushukai Hosp, Dept Plast & Reconstruct Surg, Akishima, Japan
[11] Shizuoka Saiseikai Gen Hosp, Dept Plast Surg, Shizuoka, Japan
[12] Ikoma City Hosp, Dept Plast & Reconstruct Surg, Ikoma, Japan
[13] Sendai Social Insurance Hosp, Dept Orthoped Surg, Sendai, Miyagi, Japan
[14] Juntendo Univ, Shizuoka Hosp, Dept Dermatol & Allergol, Izunokuni, Japan
[15] Tomei Atsugi Hosp, Dept Plast Surg, Atsugi, Japan
[16] Shimokitazawa Hosp, Tokyo, Japan
关键词
autologous; chronic; diabetes; diabetic foot ulcer; hard-to-heal; platelet-rich plasma; ulcer; wound; wound care; wound dressing; wound healing; PERCENT AREA REDUCTION; TRIAL; MANAGEMENT; PREDICTOR;
D O I
10.12968/jowc.2023.0088
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
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.
引用
收藏
页码:484 / 494
页数:10
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