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Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05347420
Enrollment
600
Registered
2022-04-26
Start date
2020-08-01
Completion date
2023-08-31
Last updated
2022-04-26

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

Conditions

Diabetic Peripheral Neuropathy

Brief summary

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.

Interventions

DIAGNOSTIC_TESTThe visual Neuropad test and the quantitative Neuropad 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.

Sponsors

First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1\) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
The quantitative Neuropad test1 dayThe diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

Secondary

MeasureTime frameDescription
The visual Neuropad test1 dayThe diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy

Countries

China

Outcome results

None listed

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