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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06734143
Enrollment
174
Registered
2024-12-16
Start date
2022-06-01
Completion date
2023-07-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Autonomic Neuropathy, Diabetic Neuropathy

Keywords

diabetic neuropathy, neuropad

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.

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.

Sponsors

University Hospital Tuebingen
CollaboratorOTHER
Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
sensitivity, specificity and accuracy of Neuropad to detect DAN1 yearsensitivity, specificity and accuracy of Neuropad to detect DAN

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026