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CompletedNCT06734143Updated Feb 20, 2025

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

An observational study in Diabetic Autonomic Neuropathy and Diabetic Neuropathy, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
174
Ages
Up to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Autonomic Neuropathy
  • Diabetic Neuropathy

Keywords

  • diabetic neuropathy
  • neuropad
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 174 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

people with diabetes mellitus

Inclusion criteria

  • diabetes mellitus

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
174 participants (actual)
Patient registry
No

Groups and cohorts

  • Group

    patients with diabetes mellitus

    Diagnostic Test: Neuropad

Interventions

  • Diagnostic testNeuropad

    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.

06

What researchers measure

Primary outcomes

  1. sensitivity, specificity and accuracy of Neuropad to detect DAN

    sensitivity, specificity and accuracy of Neuropad to detect DAN

    Time frame: 1 year

07

Study locations

1 site
  • University General Hospital of Thessaloniki AHEPA
    Thessaloniki, 54636, Greece
08

References and documents

Individual participant data

Plan to share: No — Data privacy reasons

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06734143
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
University Hospital Tuebingen
Responsible party
Prof. Triantafyllos Didangelos (Professor of Internal Medicine and Diabetology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Dec 16, 2024
Start date
Jun 1, 2022
Primary completion
Jun 30, 2023
Completion
Jul 31, 2023
Last update
Feb 20, 2025

Study contacts

Konstantinos Kantartzis, Professor MD
study director · University Hospital Tuebingen
Triantafyllos Didangelos, Professor MD
principal investigator · Aristotle University Of Thessaloniki

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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