新的与标准可移除减压装置在伴有神经病变的糖尿病足溃疡患者中的比较：一项法国全国性、多中心、开放性标签、随机、对照试验。

Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial.

机构信息

Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, Île-de-France, France

Université de Paris, Paris, Île-de-France, France.

出版信息

BMJ Open Diabetes Res Care. 2020 May;8(1). doi: 10.1136/bmjdrc-2019-000954.

DOI:10.1136/bmjdrc-2019-000954

PMID:32393479

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7223015/

Abstract

INTRODUCTION

The offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of in DFU healing.

RESEARCH, DESIGN AND METHODS: The evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either ), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.

RESULTS

Among 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the group than in the control group (15% vs 4%). was less frequently worn than conventional devices (46% vs 66%, p=0.04).

CONCLUSIONS

, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.

TRIAL REGISTRATION NUMBER

NCT01956162.

摘要

简介

减压对于治疗神经性糖尿病足溃疡（DFU）至关重要。可移动减压装置是最常用的设备。是一种新型定制的可移动膝高减压装置，可固定足部和踝关节，具有一些特定的创新功能，可能会改善减压效果。我们旨在评估对 DFU 愈合的效果。

研究、设计和方法：一项法国多中心（13 个中心）、随机对照、双盲终点评估的研究，评估了一种新的可移动 ORTHOsis 在糖尿病足中的减压效果。患有神经性 DFU 的成年人被随机分为两组，一组使用，另一组使用任何类型的常规（法国常用）可移动减压装置（对照组）。主要结局是 3 个月时完全愈合的 DFU 患者比例。

结果

在 112 名随机患者（男性 78%，年龄 62±10 岁）中，使用常规装置的患者中有 19 例（33%）和使用的患者中有 19 例（35%）达到主要结局（p=0.79）。两组在预设的次要结局方面也相似，包括新的 DFU 发生（常规组和实验组分别为 25%和 27%）、同侧下肢截肢（4%和 10%）或感染性并发症（14%和 13%）（所有均>0.05）。两组之间的不良事件相似，包括 4 例与研究分配无关的死亡（1 例猝死，2 例室性心律失常，1 例胰腺癌）。与对照组相比，实验组中与装置相关的不良事件更高（15%比 4%）。比常规装置更频繁地被穿戴（46%比 66%，p=0.04）。