Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care

Completed

• Conditions: Diabetic Foot
• Interventions: Diagnostic Test: Ipswich touch test

• Registration Number: NCT06288555
• Lead Sponsor: Ponlawat Hanchana, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-12-21
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-23
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• being 18 years old or older, having type 2 diabetes
• being able to communicate in Thai by speaking and listening.

Exclusion Criteria

• AIDS
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patient	Ipswich touch test	This study 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.

Primary Outcome Measures

Name	Time	Method
The accuracy of the Ipswich touch test	1 year	sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, and positive likelihood ratio

Trial Locations

Locations (1)

Ponlawat Hanchana, MD; 🇹🇭 Saraburi, Thailand