NCT06288555

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 274 (actual)
• Sponsor: Ponlawat Hanchana, MD · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ipswich touch test	Ipswich touch test: A simple test to screen for diabetic peripheral neuropathy (DPN) by lightly touching the patient's toes with the index finger and asking them to identify which foot is touched. 10g monofilament test: A more sensitive test to confirm DPN by applying a thin nylon fiber to different sites on the patient's feet and asking them to indicate when they feel the pressure. Test procedure: The patient closes their eyes and the examiner performs both tests in a specific sequence and records the results. The tests are done on healthy skin and not on wounds or calluses.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2024-03-01
• Last updated: 2024-03-05

Locations

1 site across 1 country: Thailand