NCT05347420

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 21, 2022

Last Update Submit

April 21, 2022

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • The quantitative Neuropad test

    The diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

    1 day

Secondary Outcomes (1)

  • The visual Neuropad test

    1 day

Study Arms (2)

Diabetic peripheral neuropathy

Patients with diabetic peripheral neuropathy

Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test

non diabetic peripheral neuropathy

Patient without diabetic peripheral neuropathy

Diagnostic Test: The visual Neuropad test and the quantitative Neuropad test

Interventions

The visual Neuropad test and the quantitative Neuropad testDIAGNOSTIC_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.

Diabetic peripheral neuropathynon diabetic peripheral neuropathy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes in the inpatient ward of the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Study Officials

  • Rong Li, PHD

    First Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

April 26, 2022

Record last verified: 2022-04

Locations

CN(1)