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

Completed

• Conditions: Diabetic Autonomic Neuropathy; Diabetic Neuropathy

• Registration Number: NCT06734143
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

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 Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity, specificity and accuracy of Neuropad to detect DAN	1 year	sensitivity, specificity and accuracy of Neuropad to detect DAN

Trial Locations

Locations (1)

University General Hospital of Thessaloniki AHEPA; 🇬🇷 Thessaloniki, Greece