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Risk assessment and pathogenesis of diabetic foot based on ultra-early diagnosis of diabetic peripheral neuropathy

Risk assessment and pathogenesis of diabetic foot based on ultra-early diagnosis of diabetic peripheral neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074755
Enrollment
Unknown
Registered
2023-08-15
Start date
2023-08-20
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Diabetic peripheral neuropathy

Interventions

Study one :Cross-sectional study, no intervention.
Study 2: Case Group:NA
Study 2: Control group:NA

Sponsors

Dalian University of Technology Affiliated Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. To determine the normal values of peripheral epidermal nerve density and autonomic nerve distribution density of sweat gland in healthy adults in Dalian. Inclusion criteria were: healthy adults with no symptoms of peripheral neuropathy, normal neurological examination, no history of alcohol consumption, normal blood routine, liver and kidney function, and ions, and no diabetes, Sjogren's syndrome, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, celiac disease, vitamin B12/ folic acid deficiency, thyroid disease, HIV, hepatitis B, and hepatitis C infection. 2. The diagnostic cut-off values of peripheral epidermal nerve density and autonomic nerve distribution density in diabetic peripheral neuropathy patients were determined. The inclusion criteria were: (1) patients with symptoms of peripheral nerve injury such as hand and foot numbness, pain and paresthesia; (2) The presence of acupuncture, temperature, vibration, pressure or ankle reflexes decreased or disappeared; (3) Examination of nerve conduction velocity revealed abnormalities in sensory/motor nerve amplitude, latency or conduction velocity in the lower extremities. One of the above criteria can be selected.

Exclusion criteria

Exclusion criteria: 1. To determine the normal values of peripheral epidermal nerve density and autonomic nerve distribution density of sweat gland in healthy adults in Dalian. Exclusion criteria were: adults with symptoms of peripheral neuropathy, abnormal neurological examination, history of alcohol consumption, abnormal blood routine, liver and kidney function, and ions, diabetes mellitus, Sjogren's syndrome, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, celiac disease, vitamin B12/ folic acid deficiency, thyroid disease, HIV, hepatitis B, and hepatitis C infection. 2. The diagnostic cut-off values of peripheral epidermal nerve density and autonomic nerve distribution density in diabetic peripheral neuropathy patients were determined. The exclusion criteria are:(1) Age >80 years old; (2) Cardiac function grade ?~?; (3) Severe hepatic and renal insufficiency (endogenous creatinine clearance < 50 ml/min, alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal); (4) Local skin damage, ulcer; (5) History of lidocaine allergy; (6) Abnormal coagulation function; (7) Lower limb edema; (8) Peripheral nervous system diseases not caused by diabetes have been diagnosed; (9) Central nervous system diseases, such as cerebral infarction, Parkinson's disease, Guillain-Barre syndrome, etc.; (10) Peripheral vascular diseases; (11) Connective tissue diseases, such as Sjogren's syndrome, systemic lupus erythematosus, Bert's disease, sarcoidosis, systemic vasculitis; (12) Those who do not cooperate or have mental disorders; (13) Celiac disease (wheat gum bowel disease); (14) Lyme disease.

Design outcomes

Primary

MeasureTime frame
Epidermal nerve fiber density;Sweat gland autonomic nerve fiber density;

Countries

China

Contacts

Public ContactXuhan Liu

Dalian University of Technology Affiliated Central Hospital

xuhanliu281277@hotmail.com+86 135 5596 3206

Outcome results

None listed

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