High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy

February 19, 2025 updated by: Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki

Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy: a Validation Study

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Study Type

Observational

Enrollment (Actual)

174

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

  • Greece
      • Thessaloniki, Greece, 54636
        • University General Hospital of Thessaloniki AHEPA

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

people with diabetes mellitus

Description

Inclusion Criteria:

  • diabetes mellitus

Exclusion Criteria:

  • age>75 years,
  • estimated creatinine clearance rate (using the Cockcroft-Gault formula) <30 ml/ min,
  • history of limp amputation,
  • causes of neuropathy other than diabetes,
  • drugs that can affect perspiration, and
  • skin disorders that could affect the result.

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
Group
patients with diabetes mellitus
Diagnostic test: Neuropad
Neuropad examination was performed in all patients, after 10 minutes of rest without socks in a well-temperatured room. The result was considered normal if there was a complete color change and abnormal if there was no or incomplete color change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity, specificity and accuracy of Neuropad to detect DAN
Time Frame: 1 year
sensitivity, specificity and accuracy of Neuropad to detect DAN
1 year

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Collaborators

University Hospital Tuebingen

Investigators

  • Study Director: Konstantinos Kantartzis, Professor MD, University Hospital Tuebingen
  • Principal Investigator: Triantafyllos Didangelos, Professor MD, Aristotle University Of Thessaloniki

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)

June 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16162/24.3.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data privacy reasons

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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