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

Ponlawat Hanchana, MD

Status: Completed

Conditions: Diabetic Foot

Treatments: Diagnostic Test: Ipswich touch test

Study type: Observational

Funder types: Other

Identifiers

NCT06288555

020/2566

Details and patient eligibility

About

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.

Full 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.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

274 participants in 1 patient group

Diabetic patient

Description:

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.

Treatment:

Diagnostic Test: Ipswich touch test