<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456465</url>
  </required_header>
  <id_info>
    <org_study_id>PUTH2018054</org_study_id>
    <nct_id>NCT04456465</nct_id>
  </id_info>
  <brief_title>Pain Diabetic Peripheral Neuropathy（DPN) in China</brief_title>
  <official_title>Clinical Characteristics and Treatment of Pain Diabetic Peripheral Neuropathy（DPN） in China: a Multi-center Cross-sectional Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To understand the clinical characteristics of DPN patients in China; To investigate the&#xD;
      distribution of DPN patients with depression and anxiety symptoms; To investigate the related&#xD;
      factors of moderate and severe pain in DPN patients; To investigate the treatment of pain and&#xD;
      depression and/or anxiety in DPN patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain diabetic peripheral neuropathy (DPN) is a heavy global economic burden. An American&#xD;
      observational study in 2013 showed that the total average annual adjusted direct medical&#xD;
      cost/person for DPN patients was $4,841, and the total average annual adjusted indirect&#xD;
      medical cost/person was $9,730. A retrospective study in the United States in 2015 showed&#xD;
      that the total annual direct medical cost per person for diabetes was $6,632, DPN ($12,492),&#xD;
      DPN ($27,931), and severe DPN ($30,755) were 4.6 times higher than those for patients with&#xD;
      diabetes alone. According to the 2015 European survey, the total annual direct medical cost&#xD;
      per person for DPN patients in the United Kingdom was €2,963 (£2,511), of which 40% was used&#xD;
      for hospitalization.&#xD;
&#xD;
      At present, there are no studies on the population epidemiology, depression and drug use of&#xD;
      DPN in China. This study mainly investigates the above problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>moderate and severe pain (VAS score ≥4)</measure>
    <time_frame>Time at recruitment</time_frame>
    <description>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 &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic data</measure>
    <time_frame>Time at recruitment</time_frame>
    <description>A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical manifestations of pain: VAS score</measure>
    <time_frame>Time at recruitment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression screening/assessment: PHQ-9 scale</measure>
    <time_frame>Time at recruitment</time_frame>
    <description>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 &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day), providing a 0-27 severity score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety screening/assessment: GAD-7 scale</measure>
    <time_frame>Time at recruitment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">1500</enrollment>
  <condition>Diabetic Neuropathies</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain diabetic peripheral neuropathy</intervention_name>
    <description>Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pain diabetic peripheral neuropathy（DPN） in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  outpatients who are elder than 18 years old with history of type 1or type 2 diabetes&#xD;
&#xD;
          -  The presence of symptoms, signs and/or electrophysiological evidence of diabetic&#xD;
             peripheral neuropathy&#xD;
&#xD;
          -  The patient presents spontaneous pain (continuous or intermittent acupuncture pain,&#xD;
             electric shock pain, burning pain, etc.) or induced pain (sensory hypersensitivity,&#xD;
             paresthesia, etc.)&#xD;
&#xD;
          -  The pain lasts for at least 3 months&#xD;
&#xD;
          -  Informed consent has been signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other causes of neuropathic, non-neuropathic, or mixed pain: for&#xD;
             example, cervical/lumbar degenerative diseases, arthritis, nerve root compression,&#xD;
             paraneoplastic syndromes, cerebrovascular diseases, spinal diseases, other peripheral&#xD;
             neuropathies (immunological, toxic, nutritional peripheral neuropathies, etc.)&#xD;
&#xD;
          -  Dementia, substance abuse, etc., severely affect cognitive and communication skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dongsheng Fan, MD.PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain diabetic peripheral neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Neuropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456465
org study id: PUTH2018054
nct id: NCT04456465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: moderate and severe pain (VAS score ≥4)
time frame: Time at recruitment
description: 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.
measure: Demographic data
time frame: Time at recruitment
description: A history of diabetes, diabetic peripheral neuropathy, and pain diabetic peripheral neuropathy Comorbidities such as hypertension, cardiovascular disease, a history of depressive disorders
measure: Clinical manifestations of pain: VAS score
time frame: Time at recruitment
description: 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.
measure: Depression screening/assessment: PHQ-9 scale
time frame: Time at recruitment
description: 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.
measure: Anxiety screening/assessment: GAD-7 scale
time frame: Time at recruitment
description: 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.
intervention type: Other
intervention name: Pain diabetic peripheral neuropathy
description: Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dongsheng Fan, MD.PHD
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies
sharing ipd: No