Abstract：
UNASSIGNED: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population.
UNASSIGNED: Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier analysis was used to determine median time to complete wound closure (CWC).
UNASSIGNED: The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to \'not achieved\' in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04).
UNASSIGNED: In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population.
UNASSIGNED: This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare.
UNASSIGNED: Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier analysis was used to determine median time to complete wound closure (CWC).
UNASSIGNED: The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to \'not achieved\' in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04).
UNASSIGNED: In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population.
UNASSIGNED: This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare.
摘要：
■糖尿病足溃疡（DFU）继续挑战伤口护理从业者。这个未来,多中心,随机对照试验（RCT）评估了脱水羊膜绒毛膜（dACM）的有效性（器官发生公司，在具有挑战性的患者人群中，美国）与仅在复杂DFU中的护理标准（SoC）相比。
■DFU伸入真皮的受试者，皮下组织,肌腱,胶囊,骨或关节纳入一项为期12周的试验.将它们均等地分配到两个治疗组:dACM(加SoC);或单独的SoC。主要终点是通过Cox分析确定的伤口闭合频率,其针对持续时间和伤口面积进行调整。Kaplan-Meier分析用于确定完成伤口闭合（CWC）的中位时间。
■该队列包括218名患者，这些在两个治疗组之间平均分配，每组109例患者。Cox分析表明，在第4周时，dACM加SoC组的伤口闭合估计频率在统计学上优于仅SoC组（12％对8％），第6周（22%对11%），第8周（31%对21%），第10周（42%对27%）和第12周（50%对35%），分别(p=0.04)。计算的风险比（1.48（置信区间：0.95，2.29）显示，有利于dACM组的伤口闭合概率增加了48％。dACM治疗的溃疡伤口闭合的中位时间为84天，而SoC治疗组中的“未达到”（即，≥50％的SoC治疗的DFU到第12周未能愈合；p=0.04）。
■在动力充足的DFURCT中，DACM增加了频率，减少了中位数时间，与单用SoC相比，提高了CWC的概率。dACM在复杂患者人群中对DFU表现出有益作用。
■这项研究由OrganesisInc.资助，US.JC是器官发生的顾问和演讲者。RDD是器官发生的演讲者。OMA和MLS担任器官发生顾问。作者没有其他利益冲突需要声明。
■DFU伸入真皮的受试者，皮下组织,肌腱,胶囊,骨或关节纳入一项为期12周的试验.将它们均等地分配到两个治疗组:dACM(加SoC);或单独的SoC。主要终点是通过Cox分析确定的伤口闭合频率,其针对持续时间和伤口面积进行调整。Kaplan-Meier分析用于确定完成伤口闭合（CWC）的中位时间。
■该队列包括218名患者，这些在两个治疗组之间平均分配，每组109例患者。Cox分析表明，在第4周时，dACM加SoC组的伤口闭合估计频率在统计学上优于仅SoC组（12％对8％），第6周（22%对11%），第8周（31%对21%），第10周（42%对27%）和第12周（50%对35%），分别(p=0.04)。计算的风险比（1.48（置信区间：0.95，2.29）显示，有利于dACM组的伤口闭合概率增加了48％。dACM治疗的溃疡伤口闭合的中位时间为84天，而SoC治疗组中的“未达到”（即，≥50％的SoC治疗的DFU到第12周未能愈合；p=0.04）。
■在动力充足的DFURCT中，DACM增加了频率，减少了中位数时间，与单用SoC相比，提高了CWC的概率。dACM在复杂患者人群中对DFU表现出有益作用。
■这项研究由OrganesisInc.资助，US.JC是器官发生的顾问和演讲者。RDD是器官发生的演讲者。OMA和MLS担任器官发生顾问。作者没有其他利益冲突需要声明。
