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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. [ABSTRACT FROM AUTHOR]

Recently, the number of patients with peripheral artery disease (PAD), including those with chronic limb-threatening ischemia (CLTI), has increased because of the increasing number of diabetic or dialysis patients worldwide. Revascularization is an important therapy for patients with CLTI. However, we sometimes experience refractory cases with insufficient peripheral circulation or microcirculation after revascularization. In this situation, additional therapy can be administered, such as low-density lipoprotein apheresis, high-pressure oxygen therapy, and spinal cord stimulation. However, they are not effective in some cases. Some reports have also indicated that transdermal isosorbide dinitrate patch (ISDN-P) is a useful therapy for PAD. As the efficacy of ISDN-P for patients with CLTI is not well-known, we examined it in this study. We assessed the skin perfusion pressure (SPP) after affixing an ISDN-P on the foot, because SPP measurement has proved useful in the assessment of PAD and is a good indicator of wound healing potential. The SPP (dorsal and plantar aspects) after ISDN-P application on the foot of healthy volunteers increased (n = 8; mean ± SD, 12.6 ± 7.9 [ P =.12], and 21.2 ± 7.7 mm Hg [ P <.05], respectively), as did SPP of patients with CLTI (n = 10; mean ± SD, 19.8 ± 2.5 [ P <.01], and 14.1 ± 5.9 mm Hg [ P <.05], respectively). All the patients who received an ISDN-P on the foot had no major complication, and no significant change in blood pressure. In conclusion, the ISDN-P is one of the effective and safe therapies for patients with CLTI. [ABSTRACT FROM AUTHOR]