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Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in Diabetic Peripheral Neuropathy(DPN): Association With a Target Gene

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record status
This record was last updated June 16, 2026 (before its estimated July 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study description expanded, about 1 word
    • Study title expanded, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, Matrix Metalloproteinase 9(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 Toronto 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.
Trial Details
NCT Number NCT07595887
Lead Sponsor Second Hospital of Shanxi Medical University
Conditions
(from sponsor)
Diabetic Peripheral Neuropathy (DPN)
Related terms Diabetes Mellitus, Type 2, Disease
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov