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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-01

Study Completion Date

2021-07-01

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.

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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.

Conditions

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Small Fiber Neuropathy Diabetic Neuropathies Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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sudoscan、nerve conduction tests

To evaluate sudomotor nerve and macrofibropathy.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes