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

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.

Completed

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Hypersensitivity Immune System Diseases Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ponlawat Hanchana, MD

Changwat Sara Buri, 18120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipswich touch test

Diagnostic 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.

Other names: 10-g monofilament test

Primary outcomes

The accuracy of the Ipswich touch test

Time frame: 1 year

sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, and positive likelihood ratio

Sponsors and collaborators

Lead sponsor

Ponlawat Hanchana, MD

Other Gov

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 1, 2024
Registry last updated: Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed