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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]

Key Clinical Message: This case highlights the biomechanical influence of toe amputation on contralateral limb force elevation, possibly through reduced ipsilateral plantar flexor torque production. These findings provide insight into toe amputation‐related compensatory gait mechanics with greater inter‐limb asymmetry, which may increase the risk of musculoskeletal comorbidities, including osteoarthritis in contralateral limb. [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]

Aim: An investigator‐initiated clinical study was carried out to evaluate the therapeutic potency of SR‐0379 for the treatment of leg ulcers in patients with Werner syndrome. Methods: A multicenter, open‐label study was carried out from September 2017 to February 2018. The inclusion criteria for leg ulcers were: (i) leg ulcers in patients with Werner syndrome, diabetes or critical limb ischemia/venous stasis; and (ii) a wound size of >1 cm and <6 cm in diameter. Four individuals with Werner syndrome and diabetic ulcers, respectively, were enrolled. SR‐0379 (0.1%) was sprayed on skin ulcers once per day for 4 weeks. Efficacy was evaluated by determining the rate of wound size reduction as a primary end‐point at 4 weeks after the first treatment compared with the pretreatment wound size. As secondary end‐points, the DESIGN‐R score index, the 50% wound size reduction ratio, time to wound closure and quantification of wound bacteria were also evaluated. The safety of SR‐0379 was evaluated during the study period. Results: The reduction rate of ulcer size treated with 0.1% SR‐0379 was 22.90% (mean) in the Werner syndrome ulcers group (n = 4) and 35.70% (mean) in the diabetic ulcers group (n = 4), respectively. The DESIGN‐R score decreased by 4.0 points in the Werner syndrome ulcers group and 4.3 points in the diabetic ulcers group. Two mild adverse events were reported in two patients, and causal relationships were denied in any events. Conclusion: Treatment with SR‐0379 was safe, well‐tolerated, and effective for leg ulcers of both Werner syndrome and diabetes patients. Geriatr Gerontol Int 2019; 19: 1118–1123. [ABSTRACT FROM AUTHOR]

Objective: Telemedicine is an essential support system for clinical settings outside the hospital. Recently, the importance of the model for assessment of telemedicine (MAST) has been emphasised. The development of an eHealth-supported wound assessment system using artificial intelligence is awaited. This study explored whether or not wound segmentation of a diabetic foot ulcer (DFU) and a venous leg ulcer (VLU) by a convolutional neural network (CNN) was possible after being educated using sacral pressure ulcer (PU) data sets, and which CNN architecture was superior at segmentation. Methods: CNNs with different algorithms and architectures were prepared. The four architectures were SegNet, LinkNet, U-Net and U-Net with the VGG16 Encoder Pre-Trained on ImageNet (Unet_VGG16). Each CNN learned the supervised data of sacral pressure ulcers (PUs). Results: Among the four architectures, the best results were obtained with U-Net. U-Net demonstrated the second-highest accuracy in terms of the area under the curve (0.997) and a high specificity (0.943) and sensitivity (0.993), with the highest values obtained with Unet_VGG16. U-Net was also considered to be the most practical architecture and superior to the others in that the segmentation speed was faster than that of Unet_VGG16. Conclusion: The U-Net CNN constructed using appropriately supervised data was capable of segmentation with high accuracy. These findings suggest that eHealth wound assessment using CNNs will be of practical use in the future. [ABSTRACT FROM AUTHOR]

Treating hard-to-heal skin and nail onychomycosis of diabetic foot with plasma therapy Here we show that plasma treatment is a novel alternative treatment for hard-to-treat skin and nail onychomycosis. Plasma therapy appears to have potential efficacy against hard-to-heal toe nail and foot skin onychomycosis when used in conjunction with traditional treatments. [Extracted from the article]

Chronic limb-threatening ischemia (CLTI) is a severe limb problem. The causes of foot ulcer are influenced by several factors, which lead to ischemia and foot deformity causing recurrence after wound healing. This report focuses on the long-term course. An 80-year-old male with CLTI was treated. The patient had an ulcer in the second toe of his left foot and stenosis of above the knee vessels. He performed his daily activities independently and his left foot was hallux valgus. After improving blood flow, foot deformity was corrected with ulcer treatment. The patient's second toe was amputated after the endovascular treatment. Finally, the toe was closed and hallux abductive valgus was corrected at the same time. After three years, he had no recurrence of foot ulcer. The patient uses a foot orthosis and his life is independent with no recurrence. Surgical offloading is an effective method to prevent recurrence. Surgical offloading is sometimes performed in patients with CLTI, but there is few occasion to undergo. This is because, there are problems of re-ischemia and an advanced age. Therefore, simultaneous surgery, as in this case, could be useful and help reduce the ulcer recurrence rate. Simultaneous surgery for CLTI was useful in leading to a reduction in recurrence rate. • Simultaneous surgery (surgical offloading and ulcer closed operation) could be useful and help reduce the ulcer recurrence rate, because chronic limb-threatening ischemia has a problem of recurrence. • After improvement of blood flow, chronic limb-threatening ischemia patient can be underwent surgical offloading. • Patients who have undergone simultaneous surgery can maintain a long-term quality of life. • Simultaneous surgery is relatively easy and saves surgeons time and effort to perfume surgical offloading another time. [ABSTRACT FROM AUTHOR]

An 80-year-old man was transferred to our institution with lower limb edema and worsening dyspnea following the administration of diuretic medication. Transthoracic echocardiography and computed tomography revealed a giant hepatic cyst (176×190 mm) compressing his right atrium and inferior vena cava (IVC). Laparoscopic cyst deroofing combined with omental packing and subsequent tube drainage immediately alleviated all his symptoms. The procedure was uneventful, and he was discharged without any complications on postoperative day 9; he had no recurrent symptoms or hepatic cysts at the postoperative 2-month follow-up. Therefore, a giant hepatic cyst can cause IVC syndrome, and laparoscopic deroofing is a beneficial approach for the treatment of accessible cysts.

Foot deformity is one of the causes of foot ulcers. Foot ulcers often recur due to foot deformity. Foot ulcer healing alone does not reduce the risk factor of foot ulcer recurrence. The majority of foot ulcer patients, most of whom are elderly, have foot deformities. This limits the chances of undergoing surgical off-loading following surgery. We present a case of diabetic foot ulcer (DFU) in which surgical off-loading was performed simultaneously with foot ulcer closure that did not recur for a period of 2 years following surgery. A 70-year-old diabetic male with a DFU presented to our hospital. He underwent surgical debridement followed by reconstruction surgery (stump plasty) simultaneous with surgical off-loading (metatarsal head resection). The immediate postoperative period during which he used the off-loading device was uneventful. Following this, he used orthosis. After 2 years, the foot ulcer had not recurred, and he was able to independently perform his daily activities. Simultaneous surgery (reconstructive surgery and surgical off-loading) is less likely to limit daily activities and can reduce the ulcer recurrence rate., Competing Interests: None, (© 2021 The Authors.)