NCT06732362

Brief Summary

The purpose of this study was to quantitatively standardize the performance of patients with DPN with different course of disease using high-frequency ultrasound, and to design experiments to verify the conclusion that DPN patients with peripheral nerve damage increased nerve sensitivity to local anesthetic drugs and increased block time, and to achieve the same blocking effect by using low-concentration local anesthetic drugs, so as to reduce the probability of complications such as transient nerve injury, severe nerve injury, and local anesthetic poisoning.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

December 10, 2024

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • N/OFQ

    Serum N/OFQ levels

    24 hours

Secondary Outcomes (2)

  • Time to onset of nerve block

    24 hours

  • Ratio of femoral nerve to femoral artery cross-sectional area

    24 hours

Study Arms (3)

No peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Other: Different DPN ratings

Mild peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Other: Different DPN ratings

Severe peripheral vascular neuropathy

Grouping was performed according to the TCSS grading scale

Other: Different DPN ratings

Interventions

According to the TCSS grading scale, DPN patients were graded into different grades, and the mild and severe groups and the control group were selected to observe the clinical effects between the three groups

Mild peripheral vascular neuropathyNo peripheral vascular neuropathySevere peripheral vascular neuropathy

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the Second Hospital of Shanxi Medical University from December 2024 to June 2025

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • yi Han, Doctor

    Second Hospital of Shanxi Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

August 20, 2025

Primary Completion

August 20, 2025

Study Completion

October 29, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations