<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/NCT01715766</url>
  </required_header>
  <id_info>
    <org_study_id>360806-15</org_study_id>
    <nct_id>NCT01715766</nct_id>
  </id_info>
  <brief_title>VIPER: Veterans Integrated Pain Evaluation Research</brief_title>
  <acronym>VIPER</acronym>
  <official_title>VIPER: Veterans Integrated Pain Evaluation Research- Molecular Subtypes of Chronic Pain Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Defense and Veterans Center for Integrative Pain Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Defense and Veterans Center for Integrative Pain Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to learn about the causes of different types of pain that can&#xD;
      occur in people who have had an amputation. By gathering information through blood tests,&#xD;
      photographs, a nerve test, and questionnaires, we hope to de-code how each individual's&#xD;
      special characteristics affect the type and amount of pain they experience in their amputated&#xD;
      limb.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have already shown that pain following amputation might be caused by differences in a&#xD;
      person's genes. This study may help us find out how genes affect the way you feel pain and&#xD;
      why you may feel more or less or different kinds of pain than another person with a similar&#xD;
      amputation. What we learn in this research study may lead to discoveries as to why some&#xD;
      painkillers work better for some people than others.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proteomics</measure>
    <time_frame>1 day</time_frame>
    <description>To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.</description>
  </primary_outcome>
  <enrollment type="Actual">124</enrollment>
  <condition>Pain</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood draw will consist of, two BD™ P100 tubes (2x8.5mL=17mL) where the plasma will be&#xD;
      separated by centrifuge then placed in a -80ºC freezer. Two RNA tubes (2 x 2.5mL=5mL) and one&#xD;
      DNA tube (8.5mL) will be place first, in a -20ºC freezer for 24-36 hours then moved to a&#xD;
      -80ºC freezer. All the blood samples will remain in a -80ºC freezer at the Department of&#xD;
      Clinical Investigation(DCI) laboratory until they are sent to Duke University after every 8&#xD;
      subjects.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female active duty military personnel age 18 years and older presenting with the&#xD;
        diagnosis of amputation of 1 limb in the previous 18 months. At least 3 months must have&#xD;
        passed since the first amputation procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female active duty military personnel age 18 years and older undergoing&#xD;
             treatment at WRAMC and future WRNMMC with the diagnosis of post injury amputation of 1&#xD;
             limb, more than 3 but less than 18 months prior to enrollment. In particular, phantom&#xD;
             limb pain patients will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Traumatic Brain Injury (Primary major head trauma and diagnosis of traumatic&#xD;
             brain injury resulting in documented, permanent or prolonged cognitive deficits that&#xD;
             would preclude participation in the study (i.e. decreased intellectual capacity,&#xD;
             marked memory deficits, or inability to communicate verbally or in writing)&#xD;
&#xD;
          -  Significant cognitive deficits that would preclude participation in the study.&#xD;
&#xD;
          -  Substantial hearing loss without alternative means of communication.&#xD;
&#xD;
          -  Documented spinal cord injury with permanent or persistent deficits.&#xD;
&#xD;
          -  Diagnosis of fibromyalgia or other chronic pain syndrome such as chronic headaches.&#xD;
&#xD;
          -  Evidence of ongoing tissue damage pain, infection, bone spur, or poorly fitting&#xD;
             prosthesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Proteomics study</keyword>
  <keyword>biomarker study of pain</keyword>
  <!-- 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/NCT01715766
org study id: 360806-15
nct id: NCT01715766
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to learn about the causes of different types of pain that can
      occur in people who have had an amputation. By gathering information through blood tests,
      photographs, a nerve test, and questionnaires, we hope to de-code how each individual's
      special characteristics affect the type and amount of pain they experience in their amputated
      limb.
Studies have already shown that pain following amputation might be caused by differences in a
      person's genes. This study may help us find out how genes affect the way you feel pain and
      why you may feel more or less or different kinds of pain than another person with a similar
      amputation. What we learn in this research study may lead to discoveries as to why some
      painkillers work better for some people than others.
observational model: Cohort
time perspective: Prospective
measure: Proteomics
time frame: 1 day
description: To determine which proteins represent circulating qualitative and quantitative biomarkers of pain.
Blood draw will consist of, two BD™ P100 tubes (2x8.5mL=17mL) where the plasma will be
      separated by centrifuge then placed in a -80ºC freezer. Two RNA tubes (2 x 2.5mL=5mL) and one
      DNA tube (8.5mL) will be place first, in a -20ºC freezer for 24-36 hours then moved to a
      -80ºC freezer. All the blood samples will remain in a -80ºC freezer at the Department of
      Clinical Investigation(DCI) laboratory until they are sent to Duke University after every 8
      subjects.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor