NCT06773793

Brief Summary

The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To explore the diagnostic efficacy of each parameter for DPN and establish a combined model.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2024Mar 2029

Study Start

First participant enrolled

April 7, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

January 4, 2025

Last Update Submit

January 12, 2025

Conditions

Diabetic Peripheral Neuropathy (DPN)

Outcome Measures

Primary Outcomes (1)

  • Shear Wave Velocity

    from 2024-4 to 2029-4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinically diagnosed type 2 diabetes patients, aged 18 to 75 years, without neuropathy caused by other diseases or factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210031, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Observational controlled study

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 14, 2025

Study Start

April 7, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)