Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- The accuracy of the Ipswich touch test
研究概览
简要总结
The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.
The main question it aims to answer is:
How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?
Participants underwent both the Ipswich touch test and the 10-g monofilament test.
详细描述
BACKGROUND: Diabetic foot, a severe complication of diabetes, significantly impairs the quality of life of affected individuals. However, it can be prevented through screening for loss of protective sensation in the foot. Currently, standard screening methods still require specialized equipment and trained medical professionals.
OBJECTIVES: The aim of this study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.
METHODS: This diagnostic study with a cross-sectional design focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District, Saraburi Province. Participants underwent both the Ipswich touch test and the 10-g monofilament test. Statistical analysis included evaluating sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, positive likelihood ratio, and Cohen's kappa statistic to assess the diagnostic reliability of the Ipswich touch test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being 18 years old or older, having type 2 diabetes
- •being able to communicate in Thai by speaking and listening.
排除标准
- •Alcoholism
- •Any cancer
- •Cerebrovascular disease
- •Chronic foot ulcers, or having foot or toe amputation.
- •Chronic kidney disease stage 4 and 5
- •Cirrhosis
- •Malnutrition
- •Neurological disease
- •Thyroid hormone deficiency
结局指标
主要结局
The accuracy of the Ipswich touch test
时间窗: 1 year
sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, and positive likelihood ratio
次要结局
未报告次要终点
研究者
Ponlawat Hanchana, MD
Principal Investigator
PhraPhutthabat Hospital