Diabetes Mellitus, Diabetic Neuropathies, Small Fiber Neuropathy
Conditions
Keywords
Small fiber neuropathy, Diabetic neuropathies, Skin biopsy
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.
Interventions
DEVICEsudoscan、nerve conduction tests
To evaluate sudomotor nerve and macrofibropathy.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactDalong Zhu, MD, PhD
Outcome results
None listed