Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy

Sponsor
First Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05347420
Collaborator
(none)
600
1
36
16.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test

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

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Diabetic peripheral neuropathy

Patients with diabetic peripheral neuropathy

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.

non diabetic peripheral neuropathy

Patient without diabetic peripheral neuropathy

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.

Outcome Measures

Primary Outcome Measures

  1. The quantitative Neuropad test [1 day]

    The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

Secondary Outcome Measures

  1. The visual Neuropad test [1 day]

    The diagnostic vaule of visual Neuropad for diabetic peripheral neuropathy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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;
  2. those who cannot complete the experiment as required.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400016

Sponsors and Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Investigators

  • Study Chair: Rong Li, PHD, First Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rong Li, Professor, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT05347420
Other Study ID Numbers:
  • 2020-403
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022