Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04071535
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
Study Overview
Official Title:
Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: