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

NCT06734143 | Completed

• 1 other identifier: 16162/24.3.2022
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Autonomic Neuropathy; Diabetic Neuropathy

Keywords

diabetic neuropathy; neuropad

Outcome Measures

Primary Outcomes (1)

• sensitivity, specificity and accuracy of Neuropad to detect DAN

  sensitivity, specificity and accuracy of Neuropad to detect DAN

  1 year

Study Arms (1)

Group

patients with diabetes mellitus

Diagnostic Test: Neuropad

Interventions

Neuropad DIAGNOSTIC_TEST

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.

Group

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

people with diabetes mellitus

You may qualify if:

• diabetes mellitus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• University Hospital Tuebingen: collaborator

Study Sites (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Konstantinos Kantartzis, Professor MD

  University Hospital Tuebingen

  STUDY DIRECTOR

• Triantafyllos Didangelos, Professor MD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Diabetology

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 16, 2024
• Study Start: June 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)