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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04071535
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Dalong Zhu, 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.

Condition or disease Intervention/treatment
Small Fiber Neuropathy Diabetic Neuropathies Diabetes Mellitus Device: sudoscan、nerve conduction tests

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: sudoscan、nerve conduction tests
    To evaluate sudomotor nerve and macrofibropathy.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Biospecimen Retention:   Samples With DNA
Skin sample, blood serum (approximately 3ml), and whole blood (approximately 6ml).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04071535

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Contact: Dalong Zhu, MD, PhD 13805150781

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China, Jiangsu
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Dalong Zhu, MD,PhD    86-25-83-105302   
Contact: Yan Bi, MD,PhD    86-25-83-105302   
Principal Investigator: Dalong Zhu, MD,PhD         
Sub-Investigator: Yan Bi, MD,PhD         
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications of Results:
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Responsible Party: Dalong Zhu, Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Identifier: NCT04071535     History of Changes
Other Study ID Numbers: SFNChinaDM
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The demographic and biochemical indicators of this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Small fiber neuropathy
Diabetic neuropathies
Skin biopsy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Small Fiber Neuropathy
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications