Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt

• Conditions: Painful Diabetic Peripheral Neuropathy

• Registration Number: NCT03520608
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China

Detailed Description

Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study Start: 2018-05-01
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-11-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. 18 years of age or older patients
2. definite diagnosis of type I and type II diabetes
3. evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy
4. complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion).
5. the pain lasts for at least 3 months
6. signed informed consent

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Exclusion Criteria

1. other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.)
2. dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalnce of irrational use of pain reliever drugs	baseline	percent

Secondary Outcome Measures

Name	Time	Method
Douleur Neuropathique4 questions(DN4)	baseline	unit
Visual Analogue Score(VAS)	baseline	1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain.
Patient Health Questionnaire(PHQ-9)	baseline	0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression.
Generalized Anxiety Disorder Screener (GAD-7)	baseline	0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety.

Trial Locations

Locations (1)

Dongsheng Fan; 🇨🇳 Beijing, Beijing, China