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Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in DPN: Association With a Target Gene

NCT07595887 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-19

No results posted yet for this study

Summary

Diabetic peripheral neuropathy (DPN) is a common and serious complication of diabetes that causes numbness, pain, and weakness, often starting in the feet. Currently, there is no cure, and early diagnosis is difficult with standard tests alone. This observational study aims to find better ways to detect DPN in its early stages.

The researchers will use high-frequency ultrasound, a painless and non-invasive imaging tool, to measure two things in patients with type 2 diabetes: the cross-sectional area of the sciatic nerve (to look for swelling) and the blood flow velocity in the inferior gluteal artery (a vessel that supplies the nerve).In parallel, a bioinformatics analysis has identified a key target gene, MMP9, which may play a role in nerve damage through a specific signaling pathway. The level of this protein will be measured in the patients' blood.

A total of 120 participants will be grouped by the severity of their nerve damage, assessed by a clinical scoring system (TCSS). The study will investigate whether the ultrasound measurements correlate with the clinical scores, nerve conduction studies, and the blood levels of the target protein. The ultimate goal is to combine these ultrasound structure, blood flow function, and molecular markers to build a more accurate tool for the early diagnosis and precise management of DPN, bridging the gap from early warning to mechanism-based care.

Conditions

  • Diabetic Peripheral Neuropathy (DPN)

Interventions

OTHER

No intervention (observational study)

This is a purely observational study. No investigational drug, device, or biological product will be administered, and no clinical procedures will be performed outside of standard clinical care for the sole purpose of this research. All participants will receive routine standard-of-care as determined by their treating physicians. The study will only involve non-invasive data collection including clinical assessment, ultrasound imaging, nerve conduction studies, and blood sampling for biomarker analysis, which are all conducted as part of the study assessments, not as interventions.

Sponsors & Collaborators

  • Second Hospital of Shanxi Medical University

    lead OTHER

Principal Investigators

  • Yi Han, PhD · Second Hospital of Shanxi Medical University

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2026-07-10
Completion
2026-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595887 on ClinicalTrials.gov