脱水羊膜绒毛膜与糖尿病足溃疡的标准治疗比较：一项随机对照试验。

Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial.

机构信息

Limb Preservation Platform, Inc., Fresno, CA, US.

Futuro Clinical Trials, McAllen, TX, US.

出版信息

J Wound Care. 2024 Jul 1;33(Sup7):S4-S14. doi: 10.12968/jowc.2024.0139. Epub 2024 Jun 6.

DOI:10.12968/jowc.2024.0139

PMID:38973638

Abstract

OBJECTIVE

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.

METHOD

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).

RESULTS

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).

CONCLUSION

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.

DECLARATION OF INTEREST

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

目的

糖尿病足溃疡（DFU）仍然是伤口护理从业者面临的挑战。本前瞻性、多中心、随机对照试验（RCT）评估了脱水羊膜绒毛膜（dACM）（美国组织发生公司）与单独标准治疗（SoC）在具有挑战性的患者人群中治疗复杂 DFU 的疗效。

方法

将真皮、皮下组织、肌腱、囊、骨或关节中存在 DFU 的受试者纳入为期 12 周的试验。他们被平均分配到两个治疗组：dACM（加 SoC）；或 SoC 单独治疗。主要终点是通过 Cox 分析确定的伤口闭合频率，该分析调整了持续时间和伤口面积。Kaplan-Meier 分析用于确定完全伤口闭合（CWC）的中位时间。

结果

该队列包括 218 名患者，两组各 109 名患者，两组患者人数相等。Cox 分析显示，dACM 加 SoC 组在第 4 周（12%比 8%）、第 6 周（22%比 11%）、第 8 周（31%比 21%）、第 10 周（42%比 27%）和第 12 周（50%比 35%）时伤口闭合的估计频率均具有统计学优势（p=0.04）。计算出的危害比（1.48（置信区间：0.95，2.29）表明，dACM 组伤口闭合的可能性增加了 48%。dACM 治疗的溃疡的中位愈合时间为 84 天，而 SoC 治疗组则未达到（即，≥50%的 SoC 治疗的 DFU 在第 12 周未愈合；p=0.04）。