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

• Conditions: Small Fiber Neuropathy; Diabetic Neuropathies; Diabetes Mellitus

• Registration Number: NCT04071535
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-12-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-12-31
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD)	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.

Trial Locations

Locations (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China