Diabetic Peripheral NeuropathyNCT05347420
Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- The visual Neuropad test and the quantitative Neuropad test
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to Aug 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes in the inpatient ward of the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.
Who may be able to join
- 1) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.
Who cannot join
- 1) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (eGFR ≤ 30 mL /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Rong Li, PHD, +86 23 89011552, rongli@hospital.cqmu.edu.cn
About this study
This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy
Read the detailed description
This is a diagnostic study. Every patient will undertake Neuropad test, inculding the visual and quantitative screening tests. The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. The visual and quantitative screening tests were compared when the Neuropathy Disability Score (NDS) and the Neurological Symptom Score (NSS) combined score as diagnostic criteria.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- The visual Neuropad test and the quantitative Neuropad test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The visual Neuropad test and the quantitative Neuropad testDiagnostic test
The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic peripheral neuropathy | Patients with diabetic peripheral neuropathy Receives: Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test | |
| non diabetic peripheral neuropathy | Patient without diabetic peripheral neuropathy Receives: Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantitative Neuropad test
The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy
Measured: 1 day
Secondary outcomes (1)
The visual Neuropad test
The diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Aug 2020
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Li, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Rong Li, PHD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347420
- Sponsor's protocol ID
- 2020-403
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05347420
- Acronym / sponsor ID
- 2020-403
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 26 Apr 2022 (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.
This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy
Detailed description
This is a diagnostic study. Every patient will undertake Neuropad test, inculding the visual and quantitative screening tests. The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. The visual and quantitative screening tests were compared when the Neuropathy Disability Score (NDS) and the Neurological Symptom Score (NSS) combined score as diagnostic criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic peripheral neuropathy | – | Diagnostic Test: The visual Neuropad test and the quantitative Neuropad testPatients with diabetic peripheral neuropathy |
| non diabetic peripheral neuropathy | – | Diagnostic Test: The visual Neuropad test and the quantitative Neuropad testPatient without diabetic peripheral neuropathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes in the inpatient ward of the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.
Key inclusion criteria (1 listed)
- 1) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.
Key exclusion criteria (1 listed)
- 1) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (eGFR ≤ 30 mL /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.
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 |
|---|---|---|
| The visual Neuropad test and the quantitative Neuropad testThe visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. | Diagnostic test | Diabetic peripheral neuropathy, non diabetic peripheral neuropathy |
Primary outcome
The quantitative Neuropad test
Time frame: 1 day
The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy
1 secondary outcome
The visual Neuropad test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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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.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Rong Li, PHD study chair
First Affiliated Hospital of Chongqing Medical University
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 Peripheral Neuropathy, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quantitative Neuropad test (time frame: 1 day). 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 26 Apr 2022.