Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt

Painful Diabetic Peripheral Neuropathy Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03520608
• Other study ID #: 2018182
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2018
• Source: Peking University Third Hospital
• Contact: Dongsheng Fan
• Phone: +8601082265024
• Email: dsfan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
China	Dongsheng Fan	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalnce of irrational use of pain reliever drugs	percent	baseline
Secondary	Douleur Neuropathique4 questions(DN4)	unit	baseline
Secondary	Visual Analogue Score(VAS)	1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain.	baseline
Secondary	Patient Health Questionnaire(PHQ-9)	0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression.	baseline
Secondary	Generalized Anxiety Disorder Screener (GAD-7)	0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety.	baseline