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

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    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Updated on 23 January 2021


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.


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.

Condition DIABETIC NEUROPATHY, Diabetes Mellitus, Peripheral Neuropathy, Diabetes Prevention, Diabetes Mellitus Types I and II, Small Fiber Neuropathy, Diabetes (Pediatric), diabetes mellitus (dm)
Treatment sudoscan、nerve conduction tests
Clinical Study IdentifierNCT04071535
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Last Modified on23 January 2021


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Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Prevention or DIABETIC NEUROPATHY or Peripheral Neuropathy or Diabetes (Pediatric) or Diabetes Mellitus Types I and II or diabetes mellitus (...?
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
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