<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/NCT01695629</url>
  </required_header>
  <id_info>
    <org_study_id>DPN-42377</org_study_id>
    <nct_id>NCT01695629</nct_id>
  </id_info>
  <brief_title>In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy</brief_title>
  <official_title>In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal&#xD;
      evaluation that permits non-invasive imaging of corneal structures on the cellular level.&#xD;
      Precise anatomic characterization of corneal structures, including corneal nerves, can be&#xD;
      rapidly performed with high resolution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of&#xD;
      peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low&#xD;
      risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic&#xD;
      protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek&#xD;
      to develop could ultimately be used in large-scale clinical trials and in clinical practice&#xD;
      to assess DPN severity and progression.&#xD;
&#xD;
      We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically&#xD;
      viable method to assess and quantify systemic peripheral nerve health. We emphasize that this&#xD;
      imaging method can be used in both humans and animal models to provide quantifiable,&#xD;
      longitudinal data on the same live individual to advance our understanding of the development&#xD;
      and progression of DPN, and to evaluate treatment effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>changes between control and diabetic patients</measure>
    <time_frame>12 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>None to Mild</arm_group_label>
    <description>Subjects with Diabetes with none to mild peripheral neuropathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe</arm_group_label>
    <description>Subjects with diabetes with severe neuropathy</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Skin biopsy from leg&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjes\cts with diabetes with none, mild or severe neuropathy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's&#xD;
             disease, or any known systemic neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Roni Shtein</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Ophthalmology</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT01695629
org study id: DPN-42377
nct id: NCT01695629
lead sponsor: 
has dmc: No
Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal
      evaluation that permits non-invasive imaging of corneal structures on the cellular level.
      Precise anatomic characterization of corneal structures, including corneal nerves, can be
      rapidly performed with high resolution.
Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of
      peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low
      risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic
      protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek
      to develop could ultimately be used in large-scale clinical trials and in clinical practice
      to assess DPN severity and progression.

      We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically
      viable method to assess and quantify systemic peripheral nerve health. We emphasize that this
      imaging method can be used in both humans and animal models to provide quantifiable,
      longitudinal data on the same live individual to advance our understanding of the development
      and progression of DPN, and to evaluate treatment effectiveness.
observational model: Cohort
time perspective: Prospective
measure: changes between control and diabetic patients
time frame: 12 years
arm group label: None to Mild
description: Subjects with Diabetes with none to mild peripheral neuropathy
arm group label: Severe
description: Subjects with diabetes with severe neuropathy
Skin biopsy from leg
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Roni Shtein
investigator title: Assistant Professor, Department of Ophthalmology
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Neuropathies