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局部橄榄油敷料对 1 型和 2 型糖尿病患者 1 级和 2 级糖尿病足溃疡愈合的影响:2 型糖尿病患者中评估者盲法随机对照试验。

The effect of topical olive oil dressing on the healing of grade 1 and 2 diabetic foot ulcers: An assessor-blind randomized controlled trial in type 2 diabetes patients.

机构信息

Student Research Committee, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

Department of Cellular and Molecular Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada.

出版信息

Diabetes Metab Syndr. 2022 Dec;16(12):102678. doi: 10.1016/j.dsx.2022.102678. Epub 2022 Nov 23.

Abstract

BACKGROUND AND AIMS

We aimed to compare the effect of topical olive oil dressing plus standard care with standard care alone on the treatment of grade 1 and 2 diabetic foot ulcers (DFUs) in type 2 diabetes mellitus (T2DM) patients.

METHODS

This assessor-blind randomized controlled trial included 60 T2DM patients with DFU referred to the Diabetes Clinic of Shahid Mohammadi Hospital, Bandar Abbas, Iran, from February 21 to August 22, 2017. Patients were randomly assigned to intervention (n = 30) and control (n = 30) groups. The intervention group received standard care, including wound irrigation with normal saline and oral antibiotics plus daily topical olive oil dressing for four weeks, and the control group only received standard care. The wound healing assessment scale (wound degree, color, drainage, and surrounding tissue healing) was recorded weekly and the total wound status was determined at the end of the study.

RESULTS

Treatment with olive oil led to significantly higher scores of ulcer degree, color, drainage, and surrounding tissue healing at weeks one, two, three and four in the olive oil group than in the control group (P < 0.001). Also, the total wound status score was higher in the olive oil group compared to the control group (P < 0.001). The proportions of completely healed, partially healed, and unhealed wounds were 76.6%, 23.3% and 0% in the intervention group, and 0%, 93.3% and 6.7% in the control group, respectively.

CONCLUSIONS

Topical olive oil dressing promoted the healing of DFU and it can be recommended as a safe and effective treatment in this regard.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials (IRCT), IRCT20150607022585N4. Registered 05/12/2018. Retrospectively registered, https://www.irct.ir/trial/19460.

摘要

背景与目的

我们旨在比较局部橄榄油敷料加标准护理与单独标准护理对 2 型糖尿病(T2DM)患者 1 级和 2 级糖尿病足溃疡(DFU)的治疗效果。

方法

这项评估者盲法随机对照试验纳入了 2017 年 2 月 21 日至 8 月 22 日来自伊朗班达尔阿巴斯沙希德莫哈马迪医院糖尿病诊所的 60 名 T2DM 合并 DFU 患者。患者被随机分为干预组(n=30)和对照组(n=30)。干预组接受标准护理,包括用生理盐水冲洗伤口和口服抗生素加每天局部橄榄油敷料治疗四周,对照组仅接受标准护理。每周记录伤口愈合评估量表(伤口程度、颜色、渗出和周围组织愈合),研究结束时确定总伤口状态。

结果

在橄榄油组,治疗后第 1、2、3 和 4 周,溃疡程度、颜色、渗出和周围组织愈合的评分均显著高于对照组(P<0.001)。此外,橄榄油组的总伤口状态评分也高于对照组(P<0.001)。干预组完全愈合、部分愈合和未愈合的伤口比例分别为 76.6%、23.3%和 0%,对照组分别为 0%、93.3%和 6.7%。

结论

局部橄榄油敷料促进了 DFU 的愈合,可推荐作为该方面的一种安全有效的治疗方法。

试验注册

伊朗临床试验注册中心(IRCT),IRCT20150607022585N4。注册于 2018 年 5 月 12 日。回顾性注册,https://www.irct.ir/trial/19460。

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