High Diagnostic Performance of the Indicator Plaster Neur... | NCT06734143

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

NCT06734143

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Feb 20, 2025Actual

Enrollment

174Actual

Phase

Not provided

Conditions

Diabetic Autonomic Neuropathy
Diabetic Neuropathy

Interventions

Neuropad

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

Nov 27, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2025

Last Update Posted Date

Feb 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Triantafyllos Didangelos, Professor of Internal Medicine and Diabetology, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Name	Class
University Hospital Tuebingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group		patients with diabetes mellitus	Diagnostic Test: Neuropad

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity, specificity and accuracy of Neuropad to detect DAN	sensitivity, specificity and accuracy of Neuropad to detect DAN	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

people with diabetes mellitus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstantinos Kantartzis, Professor MD	University Hospital Tuebingen	Study Director
Triantafyllos Didangelos, Professor MD	Aristotle University Of Thessaloniki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University General Hospital of Thessaloniki AHEPA		Thessaloniki		54636	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Data privacy reasons

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided