NCT05347420

Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: First Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The 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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-08-01
• Completion: 2023-08-01
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

1 site across 1 country: China