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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071535
• Other study ID #: SFNChinaDM
• Status: Recruiting
• Start date: December 1, 2015
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD, PhD
• Phone: 13805150781
• Email: zhudldr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Peripheral Nervous System Diseases
• Small Fiber Neuropathy

Intervention

Device:
• sudoscan?nerve conduction tests
To evaluate sudomotor nerve and macrofibropathy.

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (2)

Lauria G, Cornblath DR, Johansson O, McArthur JC, Mellgren SI, Nolano M, Rosenberg N, Sommer C; European Federation of Neurological Societies. EFNS guidelines on the use of skin biopsy in the diagnosis of peripheral neuropathy. Eur J Neurol. 2005 Oct;12(1 — View Citation

Van Acker N, Ragé M, Sluydts E, Knaapen MW, De Bie M, Timmers M, Fransen E, Duymelinck C, De Schepper S, Anand P, Meert T, Plaghki L, Cras P. Automated PGP9.5 immunofluorescence staining: a valuable tool in the assessment of small fiber neuropathy? BMC Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy	Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy.	December, 2019
Secondary	Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD)	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.	December, 2019