Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes

Study Overview
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Brief Summary
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To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes.

Detailed Description
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Small fiber neuropathy (SFN) is a subtype of diabetic neuropathy, patients with SFN often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. Skin biopsy is an effective method to diagnose SFN with high diagnostic accuracy. The procedure is simple and minimally, and the wound usually heals within a few days. However, skin biopsy is not widely used in diagnose of SFN in Chinese patients with diabetes. This study is aimed to establish a normal reference range of intraepidermal nerve fiber density (IENFD) in the Chinese population, and to detect SFN in Chinese patients with diabetes by skin biopsy.

Official Title
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Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes

Conditions
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Small Fiber Neuropathy, Diabetic Neuropathies, Diabetes Mellitus

Intervention / Treatment
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* Device: sudoscan、nerve conduction tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≧ 18 and ≦75 years old A history of diabetes Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes Exclusion Criteria: Acute skin infection or injury Coagulation disorders History of malignant tumor Usage of neurotoxic drugs Alcohol abuse Vascular diseases, e.g. LEASO and stroke Infectious diseases, e.g. hepatitis B, HIV, and syphilis Metabolic disorders, e.g. hypothyroidism, hyperlipidemia, and amyloid lesions Connective tissue diseases Nutritional disorders, e.g.vitamin B6 deficiency, and vitamin B12 deficiency Other causes of peripheral neuropathy, e.g. lumbar disc herniation, Guillain-Barre Syndrome, and polyradiculopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: sudoscan、nerve conduction tests|To evaluate sudomotor nerve and macrofibropathy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy | Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy. | December, 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD) | Sudoscan is used to as an autonomic nerve assessment tool with objective and stable operations, which measures the function of sweat glands by stimulating a low voltage current ( < 4 volts) and detects the electrochemical reaction between the electrodes and chloride ions in both hands and feet. Results are presented as electrochemical skin conductance in hands (HESC) and feet (FESC), asymmetry ratio value in hands (HASYM) and feet (FASYM). We use intraepidermal nerve fiber density (IENFD) measured by skin biopsy as the gold standard, sudoscan is used to evaluate its diagnostic efficiency including sensitivity and specificity of small fiber neuropathy. | December, 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small fiber neuropathy, Diabetic neuropathies, Skin biopsy