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临床试验/CTRI/2025/09/094074
CTRI/2025/09/094074尚未招募不适用

Assessment of Accuracy of the Toronto Clinical Neuropathy Scoring System and Vibration Perception Threshold in Diagnosing Diabetic Peripheral Neuropathy in Type 2 Diabetes Mellitus Patients

All India Institute of Medical Sciences Bhopal1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
86
试验地点
1
主要终点
To compare the diagnostic accuracy of the Toronto Clinical Neuropathy Scoring

研究概览

简要总结

Diabetic peripheral neuropathy is a common and serious complication of type 2 diabetes mellitus, often leading to significant morbidity including foot ulcers and amputations. While nerve conduction studies are considered the gold standard for diagnosing DPN, they are expensive, time-consuming, and not always readily available in all clinical settings. The Toronto Clinical Neuropathy Scoring System and Vibration Perception Threshold are simpler, less expensive alternatives that could potentially be used for screening and diagnosis. However, their diagnostic accuracy compared to NCS in detecting DPN has not been thoroughly established. This study aims to evaluate the effectiveness of TCNS and VPT compared to NCS, potentially providing clinicians with more accessible tools for early detection and management of DPN. The results could lead to improved screening practices, earlier interventions, and better outcomes for patients with type 2 diabetes mellitus.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of diabetes mellitus.

排除标准

  • Individuals with active foot ulcers or amputations Patients with other causes of peripheral neuropathy like Hansens disease, deficiencies etc.

结局指标

主要结局

To compare the diagnostic accuracy of the Toronto Clinical Neuropathy Scoring

时间窗: At 18 months

System and Vibration Perception Threshold with nerve conduction studies in

时间窗: At 18 months

detecting diabetic peripheral neuropathy in patients with type 2 diabetes mellitus.

时间窗: At 18 months

次要结局

  • To assess the correlation between the duration of diabetes & NCS parameters.
  • To assess the correlation between glycaemic control, lipid profile & NCS(parameters.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Helana Jabeen

All India Institute of Medical Sciences, Bhopal

研究点 (1)

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