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

March 1, 2024 updated by: Ponlawat Hanchana, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Saraburi, Thailand, 18120
        • Ponlawat Hanchana, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital(Primary care) in Phra Phutthabat District, Saraburi Province.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patient
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.
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.

Other Names:
  • 10-g monofilament test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ponlawat Hanchana, MD

Investigators

  • Principal Investigator: Ponlawat Hanchana, MD., PhraPhutthabat Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020/2566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data was save inform of Microsoft excel spreadsheet and Stata file.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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