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临床试验/NCT02308059
NCT02308059已完成不适用

Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features

Cukurova University0 个研究点目标入组 106 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
主要终点
Pain scores on the visual analog scale

研究概览

简要总结

The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.

详细描述

Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale [VAS]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes mellitus
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
  • probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.
  • Exclusion Criteria
  • type 1 diabetes mellitus
  • hypothyroidism
  • LANSS pain scale scores < 12
  • body mass index (BMI) > 35
  • current pregnancy
  • histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.

排除标准

  • 未提供

结局指标

主要结局

Pain scores on the visual analog scale

时间窗: 3 years

次要结局

  • Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bayram Kelle

Director

Cukurova University

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