<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/NCT02202668</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00083401</org_study_id>
    <nct_id>NCT02202668</nct_id>
  </id_info>
  <brief_title>Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers</brief_title>
  <official_title>Transcutaneous Raman Spectroscope Analyses of Diabetic Foot Ulcers</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>
      The primary translational research objective of the study is to demonstrate feasibility of&#xD;
      using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This&#xD;
      study represents an initial evaluation of the device in a small cohort of human patients with&#xD;
      diabetic foot ulcers. We will be evaluating safety, device design and certain human&#xD;
      engineering factors associated with point of care use of the TRS. We anticipate the data we&#xD;
      collect in this study will form the basis of later medical device studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    TRS probe performance does not meet primary outcome data requirements&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone</measure>
    <time_frame>Baseline, then monthly for 3 months</time_frame>
    <description>We will equip our portable Raman instrument with a non contact probe (PhAT probe, Kaiser Optical Systems). The probe will be placed ~ 10 inches from the wound and it will not be in contact with the wound. Depending on the size of the wound, the laser spot size on the wound bed will be 6-7.5 mm. The Raman spectra are derived from the laser light reflected back into the probe and captured by a charge coupled device (CCD) in the spectroscope. Computer software algorithms are used to deconvolute the CCD information into an interpretable Raman spectrum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound temperature post-Transcutaneous Raman Spectroscope</measure>
    <time_frame>Baseline then monthly for 3 months</time_frame>
    <description>Local temperature measurements of the wound will be collected before and immediately after the Raman measurements using a commercially available non-contact infrared thermometer which is also used to measure temperature in pediatric patients</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>TRS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TRS</intervention_name>
    <description>TRS measurements of subcutaneous deep wound soft tissue and underlying bone will be collected at the same standard locations that are used to measure wound dimensions. The probe will never be in contact with the wound, but we will sterilize the probe head in advance in order to ease potential concerns regarding equipment sterility. A single point TRS measurement can be obtained in less than 60 seconds. At a minimum we will collect measurements at the geometric center of the wound as well as at the &quot;6 and 12&quot; and &quot;3 and 9&quot; ulcer coordinates. These coordinates are commonly used to estimate ulcer dimensions. It is anticipated that the PhAT probe will be used with a beam diameter of 7.5 mm. It is possible that the incident laser beam diameter will need to be adjusted (7.5 mm to 6.0 mm) to accommodate smaller wounds. If incident laser beam diameter adjustment is necessary we will also adjust the laser intensity to maintain the maximum permissible exposure of 0.3 W/cm2 per ANSI guidelines.</description>
    <arm_group_label>TRS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus&#xD;
&#xD;
          -  Full thickness or superficial foot and ankle ulcers based on clinical assessment&#xD;
             (e.g., University of Texas (UT) grades 1-3, stages A-D). For reference, see Appendix 1&#xD;
             for the UT classification table&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 or greater than 80 years old&#xD;
&#xD;
          -  Subject has a psychological or sociological condition or an addictive disorder that&#xD;
             would preclude informed consent&#xD;
&#xD;
          -  Completely epithelialized ulcer based on clinical assessment with no ischemia or&#xD;
             infection (UT classification 0A)&#xD;
&#xD;
          -  Current or previous use of anti-resorptive bisphosphonate drugs (e.g., risedronate&#xD;
             (Actonel) and alendronate (Fosamax))&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Blake Roessler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Blake Roessler</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Foot ulcer, diabetic</keyword>
  <keyword>Spectrum analysis, Raman</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</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/NCT02202668
org study id: HUM00083401
nct id: NCT02202668
lead sponsor: 
has dmc: No
The primary translational research objective of the study is to demonstrate feasibility of
      using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This
      study represents an initial evaluation of the device in a small cohort of human patients with
      diabetic foot ulcers. We will be evaluating safety, device design and certain human
      engineering factors associated with point of care use of the TRS. We anticipate the data we
      collect in this study will form the basis of later medical device studies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Transcutaneous Raman spectra of subcutaneous deep wound soft tissue and underlying bone
time frame: Baseline, then monthly for 3 months
description: We will equip our portable Raman instrument with a non contact probe (PhAT probe, Kaiser Optical Systems). The probe will be placed ~ 10 inches from the wound and it will not be in contact with the wound. Depending on the size of the wound, the laser spot size on the wound bed will be 6-7.5 mm. The Raman spectra are derived from the laser light reflected back into the probe and captured by a charge coupled device (CCD) in the spectroscope. Computer software algorithms are used to deconvolute the CCD information into an interpretable Raman spectrum.
measure: Wound temperature post-Transcutaneous Raman Spectroscope
time frame: Baseline then monthly for 3 months
description: Local temperature measurements of the wound will be collected before and immediately after the Raman measurements using a commercially available non-contact infrared thermometer which is also used to measure temperature in pediatric patients
arm group label: TRS
arm group type: Experimental
intervention type: Device
intervention name: TRS
description: TRS measurements of subcutaneous deep wound soft tissue and underlying bone will be collected at the same standard locations that are used to measure wound dimensions. The probe will never be in contact with the wound, but we will sterilize the probe head in advance in order to ease potential concerns regarding equipment sterility. A single point TRS measurement can be obtained in less than 60 seconds. At a minimum we will collect measurements at the geometric center of the wound as well as at the "6 and 12" and "3 and 9" ulcer coordinates. These coordinates are commonly used to estimate ulcer dimensions. It is anticipated that the PhAT probe will be used with a beam diameter of 7.5 mm. It is possible that the incident laser beam diameter will need to be adjusted (7.5 mm to 6.0 mm) to accommodate smaller wounds. If incident laser beam diameter adjustment is necessary we will also adjust the laser intensity to maintain the maximum permissible exposure of 0.3 W/cm2 per ANSI guidelines.
arm group label: TRS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Blake Roessler, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Blake Roessler
investigator title: Professor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer