{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T02:14:20Z","timestamp":1790475260941,"version":"4.1.0"},"reference-count":32,"publisher":"Mark Allen Group","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Wound Care"],"published-print":{"date-parts":[[2024,7,2]]},"abstract":"<jats:sec><jats:title>Objective:<\/jats:title><jats:p>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 \u22654 weeks of standard of care (SoC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method:<\/jats:title><jats:p>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 \u226550% reduction in wound radius at the final evaluation (achievement criterion, \u226560% 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p>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\u201390.9%) patients who achieved \u226550% 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Declaration of interest:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.12968\/jowc.2023.0088","type":"journal-article","created":{"date-parts":[[2024,7,5]],"date-time":"2024-07-05T12:03:49Z","timestamp":1720181029000},"page":"484-494","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan"],"prefix":"10.12968","volume":"33","author":[{"given":"Norihiko","family":"Ohura","sequence":"first","affiliation":[{"name":"Department of Plastic, Reconstructive Surgery, Kyorin University School of Medicine, Tokyo, Japan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chu","family":"Kimura","sequence":"additional","affiliation":[{"name":"Department of Plastic and Reconstructive Surgery, Hakodate General Central Hospital, Hakodate, 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