<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/NCT03787862</url>
  </required_header>
  <id_info>
    <org_study_id>HSI in Foot Surgery</org_study_id>
    <nct_id>NCT03787862</nct_id>
  </id_info>
  <brief_title>Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients</brief_title>
  <acronym>HSI</acronym>
  <official_title>Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable&#xD;
      clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.&#xD;
&#xD;
      There are a number of disorders where blood flow is inadequate to provide nutrients and&#xD;
      oxygen to tissues. Under some circumstances, surgery is required to either improve the blood&#xD;
      flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood&#xD;
      supply to an organ is temporarily or permanently performed to minimize blood loss during a&#xD;
      surgical procedure.&#xD;
&#xD;
      Additionally, there are disorders where the location of certain blood containing structures&#xD;
      is important but not immediately obvious to surgeons during an operation. Knowledge of where&#xD;
      those structures are is very important and could greatly improve the safety of various&#xD;
      surgical procedures.&#xD;
&#xD;
      Patients of the investigator who are scheduled for foot surgery will be provided the&#xD;
      opportunity to participate in this research. After giving informed consent, hyperspectral&#xD;
      images will be obtained at various points during the surgical procedure.&#xD;
&#xD;
      As this technology is non-invasive, it is not expected to interfere with or change the&#xD;
      procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved&#xD;
      to a disk for later evaluation.&#xD;
&#xD;
      100 subjects will participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hyperspectral imager will be turned on at various time points during surgery, to measure&#xD;
      the spectral wavelengths of tissues. The surgery being performed will in no way be altered by&#xD;
      the imaging device and post surgical follow-up of patients will be standard of care&#xD;
      appropriate to the surgical procedure.&#xD;
&#xD;
      Patients will have HSI performed only during their surgery. They will not receive additional&#xD;
      medications and will have no additional follow up. Participating in this study will not add&#xD;
      extra appointments, procedures, or time requirements for the patient. The patient's medical&#xD;
      record may be referenced for information after the surgery for up to one year. There are no&#xD;
      costs to the patient for participation in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI No longer with the University&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 13, 2014</start_date>
  <completion_date type="Actual">June 13, 2015</completion_date>
  <primary_completion_date type="Anticipated">June 13, 2014</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>Correlation of HSI images with patient outcomes</measure>
    <time_frame>1 year</time_frame>
    <description>Patient video images will be correlated with individual outcomes. Patients undergoing similar procedures will then be compared in terms of surgical outcome and differences in hyperspectral imaging variables.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Foot Ulcers</condition>
  <condition>Osteomyelitis</condition>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Hyperspectral Imaging (HSI)</arm_group_label>
    <description>Patients scheduled for foot surgery will be imaged using the HSI device. Data will be gathered from the electronic medical record for one year to determines the outcomes of the surgery, any complications, re-hosptializations, re-ulcerations or amputation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the investigator scheduled for foot surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  18 years or older undergoing foot surgery&#xD;
&#xD;
          -  Speak and read English or Spanish.&#xD;
&#xD;
          -  Able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give written informed consent&#xD;
&#xD;
          -  Patients who cannot speak and read English or Spanish will be excluded.&#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>Lawrence A Lavery, DPM, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkland Health and Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>June 13, 2014</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Foot ulcers</keyword>
  <keyword>Foot Surgery</keyword>
  <keyword>Hyperspectral imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Foot 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/NCT03787862
org study id: HSI in Foot Surgery
nct id: NCT03787862
lead sponsor: 
collaborator: 
has dmc: No
To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable
      clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.

      There are a number of disorders where blood flow is inadequate to provide nutrients and
      oxygen to tissues. Under some circumstances, surgery is required to either improve the blood
      flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood
      supply to an organ is temporarily or permanently performed to minimize blood loss during a
      surgical procedure.

      Additionally, there are disorders where the location of certain blood containing structures
      is important but not immediately obvious to surgeons during an operation. Knowledge of where
      those structures are is very important and could greatly improve the safety of various
      surgical procedures.

      Patients of the investigator who are scheduled for foot surgery will be provided the
      opportunity to participate in this research. After giving informed consent, hyperspectral
      images will be obtained at various points during the surgical procedure.

      As this technology is non-invasive, it is not expected to interfere with or change the
      procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved
      to a disk for later evaluation.

      100 subjects will participate in this study.
The hyperspectral imager will be turned on at various time points during surgery, to measure
      the spectral wavelengths of tissues. The surgery being performed will in no way be altered by
      the imaging device and post surgical follow-up of patients will be standard of care
      appropriate to the surgical procedure.

      Patients will have HSI performed only during their surgery. They will not receive additional
      medications and will have no additional follow up. Participating in this study will not add
      extra appointments, procedures, or time requirements for the patient. The patient's medical
      record may be referenced for information after the surgery for up to one year. There are no
      costs to the patient for participation in this study.
observational model: Case-Only
time perspective: Prospective
measure: Correlation of HSI images with patient outcomes
time frame: 1 year
description: Patient video images will be correlated with individual outcomes. Patients undergoing similar procedures will then be compared in terms of surgical outcome and differences in hyperspectral imaging variables.
arm group label: Hyperspectral Imaging (HSI)
description: Patients scheduled for foot surgery will be imaged using the HSI device. Data will be gathered from the electronic medical record for one year to determines the outcomes of the surgery, any complications, re-hosptializations, re-ulcerations or amputation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence A Lavery, DPM, MPH
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteomyelitis
mesh term: Foot Ulcer