<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/NCT01675583</url>
  </required_header>
  <id_info>
    <org_study_id>WoundImager-2012-01</org_study_id>
    <secondary_id>5R44HL059807-06</secondary_id>
    <nct_id>NCT01675583</nct_id>
  </id_info>
  <brief_title>Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)</brief_title>
  <official_title>Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CW Optics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>CW Optics, Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of an optical device designed and&#xD;
      developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized&#xD;
      that the blood flow velocity of the wound site will provide critical information on the&#xD;
      efficacy of hyperbaric oxygen therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood flow velocity measurements</measure>
    <time_frame>5 months</time_frame>
    <description>Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>Standard Care Group</arm_group_label>
    <description>Subjects who will undergo only standard wound care management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperbaric Oxygen Therapy Group</arm_group_label>
    <description>Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who have chronic lower extremity wounds will be recruited from the patient&#xD;
        population at Winchester Medical Center for enrollment in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects age 21 or older with the following types of wounds and who are able to comply&#xD;
             with the study requirements:&#xD;
&#xD;
               -  Necrotizing fasciitis&#xD;
&#xD;
               -  Compromised/failed skin grafts/flaps&#xD;
&#xD;
               -  Chronic refractory osteomyelitis&#xD;
&#xD;
               -  Soft tissue radiation necrosis&#xD;
&#xD;
               -  Diabetic wounds, lower extremity&#xD;
&#xD;
               -  Acute peripheral arterial insufficiency&#xD;
&#xD;
               -  Crush injury&#xD;
&#xD;
               -  Venous leg disease&#xD;
&#xD;
               -  Pressure ulcer&#xD;
&#xD;
               -  Other chronic, non-healing wounds&#xD;
&#xD;
          -  Subjects must have signed the Informed Consent Forms.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Female subjects who are pregnant or nursing.&#xD;
&#xD;
          -  Anyone who is unable to give written informed consent&#xD;
&#xD;
          -  Subjects with end-stage renal disease or who require peritoneal or hemodialysis.&#xD;
&#xD;
          -  Subjects with current malignancies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Winchester Medical Center</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>June 28, 2013</last_update_submitted>
  <last_update_submitted_qc>June 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Wounds</keyword>
  <keyword>Hyperbaric Oxygen</keyword>
  <keyword>Laser Speckle Imaging</keyword>
  <keyword>Hyperbaric Oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT01675583
org study id: WoundImager-2012-01
secondary id: 5R44HL059807-06
nct id: NCT01675583
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to investigate the efficacy of an optical device designed and
      developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized
      that the blood flow velocity of the wound site will provide critical information on the
      efficacy of hyperbaric oxygen therapy.
observational model: Case-Control
time perspective: Retrospective
measure: Blood flow velocity measurements
time frame: 5 months
description: Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made.
arm group label: Standard Care Group
description: Subjects who will undergo only standard wound care management.
arm group label: Hyperbaric Oxygen Therapy Group
description: Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries