Clinical trial NCT04071535: Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
Official title: Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Fiber Neuropathy
Diabetic Neuropathies
Diabetes Mellitus
Keywords: Small fiber neuropathy
Diabetic neuropathies
Skin biopsy
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy
timeFrame: December, 2019
Secondary outcomes:
measure: Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD)
timeFrame: December, 2019
Other outcomes:
Locations:
city: Nanjing
country: China
facility: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References:
citation: 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(10):747-58. doi: 10.1111/j.1468-1331.2005.01260.x.
citation: Van Acker N, Rage 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 Res Notes. 2016 May 23;9:280. doi: 10.1186/s13104-016-2085-4.