Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test

• Registration Number: NCT05347420
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Primary Completion: 2022-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non diabetic peripheral neuropathy	The visual Neuropad test and the quantitative Neuropad test	Patient without diabetic peripheral neuropathy
Diabetic peripheral neuropathy	The visual Neuropad test and the quantitative Neuropad test	Patients with diabetic peripheral neuropathy

Primary Outcome Measures

Name	Time	Method
The quantitative Neuropad test	1 day	The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

Secondary Outcome Measures

Name	Time	Method
The visual Neuropad test	1 day	The diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China