An observational study in Diabetes Mellitus, Type 2, sponsored by Zheng Guo. Not yet recruiting at 1 site in China. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Zheng Guo · Observational
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.
Clinically, through the correlation study between the serum choliphin concentration and the degree of neuropathy (cross-sectional area) of patients with DPN (scale standardization) of different course of disease and the degree of neuropathy under ultrasound, the DPN was standardized after conclusion, and then the clinical study was designed to use low concentrations of ropivacaine to perform nerve blocks at the same site in patients with DPN of different grades, and the time t of the first use of the analgesic pump after the primary outcome measures, the electrical stimulation threshold during nerve block, and the secondary outcome indicators were the threshold of electrical stimulation during nerve block, Sensory and motor block time-to-occur to assess the effect of nerve block.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 60 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Zheng Guo is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Patients in the Second Hospital of Shanxi Medical University from December 2024 to June 2025
Inclusion Criteria:All patients met the 1999 WHO diagnostic criteria for diabetes.
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Exclusion Criteria:(1) Type 1 diabetes; (2) Peripheral neuropathy obviously caused by other reasons; (3) Patients with neuropathy caused by diabetic foot ulcers and gangrene, as well as known history of bone and joint trauma or surgery of the lower limbs; (4) Contraindications to peripheral nerve block (such as local anesthetic allergy, coagulation dysfunction, peripheral infection, etc.) (5) Contraindications to drug components of postoperative analgesic pumps; (6) Existing opioid therapy.
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Grouping was performed according to the TCSS grading scale
Other: Different DPN ratings
Grouping was performed according to the TCSS grading scale
Other: Different DPN ratings
Grouping was performed according to the TCSS grading scale
Other: Different DPN ratings
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
N/OFQ
Serum N/OFQ levels
Time frame: 24 hours
Time to onset of nerve block
The sensorimotor disappearance time was observed after self-administration
Time frame: 24 hours
Ratio of femoral nerve to femoral artery cross-sectional area
The ratio of the two was measured to observe the change
Time frame: 24 hours
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Zheng Guo