NCT04071535

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Small Fiber Neuropathy
• Diabetic Neuropathies
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	sudoscan、nerve conduction tests	To evaluate sudomotor nerve and macrofibropathy.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-31
• Completion: 2021-07-01
• First posted: 2019-08-28
• Last updated: 2019-08-28

Locations

1 site across 1 country: China