Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China

INTRODUCTION: Painful diabetic peripheral neuropathy (PDN) is a growing public health problem in China. Despite recent progress in treatment, there has been no nationwide study evaluating current medical practices and compliance with treatment guidelines. The primary aims of this study are to investigate the clinical characteristics and treatment practices for PDN and associated anxiety and depression in China. METHODS AND ANALYSIS: Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts is a cross-sectional, multicentre registry study with a target sample size of approximately 1500 people experiencing PDN. People with PDN will be treated according to current guidelines and local practices. The demographics, medical histories, Visual Analogue Scale pain scores, Patient Health Questionnaire-9 results, Generalised Anxiety Disorder-7 scores and therapies will be recorded to evaluate clinical characteristics of PDN and current treatment practices for pain, anxiety and depression. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Peking University Third Hospital Medical Science Research Ethics Committee (2018–182). The results of this study will be disseminated through peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER: NCT03520608