SALT LAKE CITY, Feb. 26, 2024 (GLOBE NEWSWIRE) -- PolarityTE today announced the Screening of the first subject in the Phase III pivotal study evaluating SkinTE in the investigational treatment of Wagner grade 1 diabetic foot ulcers (DFUs), entitled 'Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE II,' or 'COVER DFUS II.'  COVER DFUS II will enroll up to 120 subjects at up to 20 clinical sites in the United States.  Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone.  The primary endpoint is the incidence of DFUs closed at 12 weeks.  Secondary endpoints include percent area reduction (PAR) at 4, 8, and 12 weeks; Total number of in-person wound care clinic visits and/or hospital days related to the index ulcer from Randomization Visit (RV1); Total days of CAM Boot use related to the index ulcer from Randomization Visit (RV1); Time to closure within 24 weeks; and Proportion of subjects experiencing treatment-emergent AEs between SOC and SkinTE arms.

盐湖城，2024年2月26日（环球通讯社）--PolarityTE今天宣布筛选第三阶段关键研究中的第一个受试者，该研究评估了SkinTE在Wagner 1级糖尿病足溃疡（DFU）研究性治疗中的作用，题为“SkinTE II通过DFU的血管化上皮再生获得的闭合”，或“COVER DFUs II”COVER DFUS II将在美国多达20个临床站点招募多达120名受试者。受试者将被随机分配到两个治疗组之一，接受SkinTE加标准护理（SOC）或单独接受SOC。主要终点是DFUs在12周时关闭的发生率。次要终点包括4,8和12周的面积减少百分比（PAR）；随机化访视（RV1）中与指数溃疡相关的亲自伤口护理诊所就诊总数和/或住院天数；随机访视（RV1）中与指数溃疡相关的CAM引导使用总天数；24周内关闭时间；以及SOC和SkinTE组之间出现治疗紧急AE的受试者比例。

COVER DFUS II is a pivotal study that PolarityTE will conduct under its open IND for SkinTE. Nikolai Sopko, MD, PhD, Chief Operating and Scientific Officer, commented, “DFUs often persist because the tissues within the wound bed are biologically exhausted. We are excited to evaluate how the optimized healthy cells from the patient in SkinTE can facilitate closure in these difficult-to-treat ulcers.

COVER DFUS II是PolarityTE将在其对SkinTE的开放IND下进行的一项关键研究。首席运营官和科学官尼古拉·索普科（NikolaiSopko）医学博士、博士评论道：“DFUs经常持续存在，因为伤口床内的组织在生物学上已经耗尽。我们很高兴评估斯金特患者的优化健康细胞如何促进这些难治性溃疡的闭合。

We are thankful for the patients and investigators whose participation makes this trial possible.” Dr. David Armstrong, Professor of Surgery and director of the Southwestern Academic Limb Salvage Alliance (SALSA) at the Keck School of Medicine and board director of PolarityTE, commented, “Every second, someone around t.

我们感谢患者和研究人员的参与，他们的参与使这项试验成为可能。”凯克医学院外科教授、西南学术保肢联盟（SALSA）主任、PolarityTE董事会主任大卫·阿姆斯特朗博士评论道：“每一秒，t。