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Diagnostic value of shear-wave elastography in diabetic peripheral neuropathy

Diagnostic value of shear-wave elastography in diabetic peripheral neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058061
Enrollment
Unknown
Registered
2022-03-28
Start date
2022-03-30
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Polyneuropathy (DPN)

Interventions

Gold Standard:All patients with diabetes underwent nerve conduction function tests (NCS) to assess neuropathy and were divided into two groups based on NCS results
Index test:Routine ultrasound (US) and elastic shear wave imaging (SWE) were performed on the tibial nerve and common peroneal nerve of both lower limbs in all patients with diabetes

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of healthy volunteers: (1) Aged >18 years; (2) Cooperate with B ultrasound examination. 2. Inclusion criteria for ordinary diabetic patients: diabetes diagnosis is mainly based on WHO diabetes diagnosis criteria in 1999, that is, meeting one of the following three criteria plus diabetes symptoms (such as typical three more and one less’’ symptoms) : (1) Random blood glucose > 11.1mmol/L; (2) Fasting blood glucose > 7.0mmol/L; (3) OGTT 2-hour blood glucose (glucose tolerance test was greater than 11.1mmol/L. If the tested person has no obvious symptoms of diabetes, the diagnosis needs to be verified on another day. 3. Inclusion criteria for diabetic peripheral neuropathy patients: DPN patients are diagnosed according to positive NCS results and positive signs or symptoms of neuropathy. (1) Patients with negative NCS results and negative signs and symptoms are considered DPN-free. The clinical criteria for DPN require the presence of more than one symptom (numbness, tingling, weakness, foot pain, and ataxia) or signs consistent with a pattern of distal symmetrical neuropathy (abnormal knee or ankle reflexia and temperature, light contact, monfilaments, or vibrations); (2) Positive NCS and positive clinical symptoms or signs were included in DPN group; otherwise, it was diagnosed as possible DPN and excluded. Patients with negative NCS and negative clinical signs or symptoms were included in the non-DPN group.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for healthy volunteers: (1) Diabetes mellitus; (2) A known history of other causes of polyneuropathy, such as genetics; (3) Alcohol, metabolism, cervical and lumbar lesions or toxic factors; (4) Skin lesions or swelling that interfere with nerve conduction; (5) History of cerebral infarction and other central nervous system; (6) Known leg or ankle fractures or surgical history. 2. Exclusion criteria for common diabetic patients: (1) Type 1 diabetes; (2) A known history of other causes of polyneuropathy, such as genetics; (3) Alcohol, metabolism, cervical and lumbar lesions or toxic factors; (4) Skin lesions or swelling that interfere with nerve conduction; (5) History of cerebral infarction and other central nervous system; (6) Known leg or ankle fractures or surgical history. 3. Excluded diagnosis of diabetic peripheral neuropathy: (1) Type 1 diabetes; (2) A known history of other causes of polyneuropathy, such as genetics; (3) Alcohol, metabolism, cervical and lumbar lesions or toxic factors; (4) Skin lesions or swelling that interfere with nerve conduction; (5) History of cerebral infarction and other central nervous system; (6) Known leg or ankle fractures or surgical history.

Design outcomes

Primary

MeasureTime frame
Young's modulus;

Secondary

MeasureTime frame
Cross-sectional area;The perimeter;Diameter before and after;

Countries

China

Contacts

Public ContactWei Zairong
zairongwei@163.com+86 852 28608340

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026