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

NCT06734143 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2025-02-20

No results posted yet for this 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.

Conditions

  • Diabetic Autonomic Neuropathy
  • Diabetic Neuropathy

Interventions

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.

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Konstantinos Kantartzis, Professor MD · University Hospital Tuebingen

  • Triantafyllos Didangelos, Professor MD · Aristotle University Of Thessaloniki

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-06-30
Completion
2023-07-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734143 on ClinicalTrials.gov