Diabetic Autonomic NeuropathyNCT06734143
High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy
An observational study of Diabetic Autonomic Neuropathy and Diabetic Neuropathy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Diabetic Autonomic Neuropathy, Diabetic Neuropathy
- What is being tested?
- Neuropad
- How many people
- 174 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: people with diabetes mellitus
Who may be able to join
- diabetes mellitus
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
About this study
Official title: Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy: a Validation Study
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.
- Conditions
- Diabetic Autonomic Neuropathy, Diabetic Neuropathy
- Being tested
- Neuropad
- Keywords
- diabetic neuropathy, neuropad
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuropadDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Group | patients with diabetes mellitus Receives: Diagnostic Test: Neuropad |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity and accuracy of Neuropad to detect DAN
sensitivity, specificity and accuracy of Neuropad to detect DAN
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Autonomic NeuropathyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Principal investigator, Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki
- Investigators
- Konstantinos Kantartzis, Professor MD, Study director, University Hospital TuebingenTriantafyllos Didangelos, Professor MD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734143
- Sponsor's protocol ID
- 16162/24.3.2022
- Status last verified
- Feb 2025
- First submitted
- 27 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data privacy reasons
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy: a Validation Study
- ClinicalTrials.gov ID
- NCT06734143
- Acronym / sponsor ID
- 16162/24.3.2022
- Conditions
- Diabetic Autonomic Neuropathy, Diabetic Neuropathy
- Keywords
- diabetic neuropathy, neuropad
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Diagnostic Test: Neuropadpatients with diabetes mellitus |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people with diabetes mellitus
Key inclusion criteria (1 listed)
- diabetes mellitus
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuropadNeuropad 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. | Diagnostic test | Group |
Primary outcome
sensitivity, specificity and accuracy of Neuropad to detect DAN
Time frame: 1 year
sensitivity, specificity and accuracy of Neuropad to detect DAN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. Data privacy reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Kantartzis, Professor MD study director
University Hospital Tuebingen
Triantafyllos Didangelos, Professor MD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Autonomic Neuropathy and Diabetic Neuropathy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity and accuracy of Neuropad to detect DAN (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.