Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347420
• Other study ID #: 2020-403
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quantitative Neuropad test	The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy	1 day
Secondary	The visual Neuropad test	The diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy	1 day