Pain Diabetic Peripheral Neuropathy（DPN) in China

July 1, 2020 updated by: Peking University Third Hospital

Clinical Characteristics and Treatment of Pain Diabetic Peripheral Neuropathy（DPN） in China: a Multi-center Cross-sectional Survey

To understand the clinical characteristics of DPN patients in China; To investigate the distribution of DPN patients with depression and anxiety symptoms; To investigate the related factors of moderate and severe pain in DPN patients; To investigate the treatment of pain and depression and/or anxiety in DPN patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pain diabetic peripheral neuropathy (DPN) is a heavy global economic burden. An American observational study in 2013 showed that the total average annual adjusted direct medical cost/person for DPN patients was $4,841, and the total average annual adjusted indirect medical cost/person was $9,730. A retrospective study in the United States in 2015 showed that the total annual direct medical cost per person for diabetes was $6,632, DPN ($12,492), DPN ($27,931), and severe DPN ($30,755) were 4.6 times higher than those for patients with diabetes alone. According to the 2015 European survey, the total annual direct medical cost per person for DPN patients in the United Kingdom was €2,963 (£2,511), of which 40% was used for hospitalization.

At present, there are no studies on the population epidemiology, depression and drug use of DPN in China. This study mainly investigates the above problems.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pain diabetic peripheral neuropathy（DPN） in China

Description

Inclusion Criteria:

  • outpatients who are elder than 18 years old with history of type 1or type 2 diabetes
  • The presence of symptoms, signs and/or electrophysiological evidence of diabetic peripheral neuropathy
  • The patient presents spontaneous pain (continuous or intermittent acupuncture pain, electric shock pain, burning pain, etc.) or induced pain (sensory hypersensitivity, paresthesia, etc.)
  • The pain lasts for at least 3 months
  • Informed consent has been signed

Exclusion Criteria:

  • Patients with other causes of neuropathic, non-neuropathic, or mixed pain: for example, cervical/lumbar degenerative diseases, arthritis, nerve root compression, paraneoplastic syndromes, cerebrovascular diseases, spinal diseases, other peripheral neuropathies (immunological, toxic, nutritional peripheral neuropathies, etc.)
  • Dementia, substance abuse, etc., severely affect cognitive and communication skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
moderate and severe pain (VAS score ≥4)
Time Frame: Time at recruitment
The correlation factors of moderate and severe pain (VAS score ≥4) were analyzed exploratively. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time at recruitment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: Time at recruitment
A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders
Time at recruitment
Clinical manifestations of pain: VAS score
Time Frame: Time at recruitment
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. A higher score indicates greater pain intensity.
Time at recruitment
Depression screening/assessment: PHQ-9 scale
Time Frame: Time at recruitment
The Patient Health Questionnaire (PHQ)-9 is the major depressive disorder (MDD) module of the full PHQ. Scores each of the criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score.
Time at recruitment
Anxiety screening/assessment: GAD-7 scale
Time Frame: Time at recruitment
Generalized Anxiety Disorder 7-Item Scale (GAD-7): This symptom assessment tool measures seven anxiety symptoms on 4-point scales. Average time to complete: 3 minutes. Interpretation: Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety.
Time at recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUTH2018054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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