Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
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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.
Condition or disease
Small Fiber NeuropathyDiabetic NeuropathiesDiabetes Mellitus
Device: sudoscan、nerve conduction tests
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.
Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy [ Time Frame: December, 2019 ]
Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy.
Secondary Outcome Measures :
Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD) [ Time Frame: December, 2019 ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.
Age ≧ 18 and ≦75 years old
A history of diabetes
Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes
Acute skin infection or injury
History of malignant tumor
Usage of neurotoxic drugs
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