Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (SCOPE)

P

Peking University

Status

Unknown

Conditions

Painful Diabetic Peripheral Neuropathy

Study type

Observational

Funder types

Other

Identifiers

NCT03520608
2018182

Details and patient eligibility

About

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

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Dongsheng Fan

Data sourced from clinicaltrials.gov

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