<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/NCT03034161</url>
  </required_header>
  <id_info>
    <org_study_id>206042</org_study_id>
    <nct_id>NCT03034161</nct_id>
  </id_info>
  <brief_title>Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers</brief_title>
  <official_title>Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in&#xD;
      this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be&#xD;
      included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages&#xD;
      of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal&#xD;
      distribution can be identified which can then be applied to identify patients at risk of&#xD;
      developing pressure ulcers at an earlier stage in their hospital course.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single-center prospective Phase I study in which the use of a thermal&#xD;
      imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. The&#xD;
      data collected during this study will be used to determine if stage-specific thermal&#xD;
      distribution patterns can be identified. This information will then be used to design future&#xD;
      studies in which patients are risk for the development of pressure ulcers are screened for&#xD;
      the presence of pressure ulcers not detectable upon physical examination so that preventative&#xD;
      measures and treatments can be instituted.&#xD;
&#xD;
      A total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this&#xD;
      study. The investigators plan to enroll ten patients with each stage of pressure ulcer (i.e.&#xD;
      Stage I-IV), which will provide the investigators with a set of thermal imaging data from&#xD;
      which the investigators will determine if thermal distribution patterns unique to each stage&#xD;
      of pressure ulcer can be identified. It is anticipated that 40 patients who meet the&#xD;
      inclusion criteria and distribution of pressure ulcer staging will be enrolled within one&#xD;
      year of the start date of this study.&#xD;
&#xD;
      The investigators are planning a study of a continuous response variable from independent&#xD;
      control and experimental subjects with 1 control(s) per experimental subject. It is estimated&#xD;
      that the response within each subject group will be normally distributed with standard&#xD;
      deviation 25. If the true difference in the experimental and control means is 35, the&#xD;
      investigators will need to study 9 experimental subjects and 9 control subjects to be able to&#xD;
      reject the null hypothesis that the population means of the experimental and control groups&#xD;
      are equal with probability (power) 0.8. The Type I error probability associated with this&#xD;
      test of this null hypothesis is 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    lack of funding&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">April 29, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Difference in temperature between a Stage I, Stage 2, Stage 3 and Stage 4 decubitus pressure ulcer as measured by using the thermal imaging camera.</measure>
    <time_frame>Up to one year</time_frame>
    <description>Each subject will receive one temperature measurement during inpatient status of the decubitus pressure ulcer using the thermal imaging camera.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Decubitus Ulcer</condition>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>Stage I Pressure Ulcer</arm_group_label>
    <description>Ten patients with a Stage I decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage II Pressure Ulcer</arm_group_label>
    <description>Ten patients with a Stage II decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage III Pressure Ulcer</arm_group_label>
    <description>Ten patients with a Stage III decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage IV Pressure Ulcer</arm_group_label>
    <description>Ten patients with a Stage IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermal imaging</intervention_name>
    <description>Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.</description>
    <arm_group_label>Stage I Pressure Ulcer</arm_group_label>
    <arm_group_label>Stage II Pressure Ulcer</arm_group_label>
    <arm_group_label>Stage III Pressure Ulcer</arm_group_label>
    <arm_group_label>Stage IV Pressure Ulcer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sacral/heel pressure ulcers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with sacral/heel pressure ulcers, admitted to University of Arkansas for&#xD;
             Medical Sciences (UAMS) inpatient services.&#xD;
&#xD;
          -  Patients 18-years old or older.&#xD;
&#xD;
          -  Patients have an expected survival of &gt; 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not compliant with obtaining thermal imaging.&#xD;
&#xD;
          -  Patients not expected to survive for 48 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob T Carlson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03034161
org study id: 206042
nct id: NCT03034161
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in
      this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be
      included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages
      of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal
      distribution can be identified which can then be applied to identify patients at risk of
      developing pressure ulcers at an earlier stage in their hospital course.
This study will be a single-center prospective Phase I study in which the use of a thermal
      imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. The
      data collected during this study will be used to determine if stage-specific thermal
      distribution patterns can be identified. This information will then be used to design future
      studies in which patients are risk for the development of pressure ulcers are screened for
      the presence of pressure ulcers not detectable upon physical examination so that preventative
      measures and treatments can be instituted.

      A total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this
      study. The investigators plan to enroll ten patients with each stage of pressure ulcer (i.e.
      Stage I-IV), which will provide the investigators with a set of thermal imaging data from
      which the investigators will determine if thermal distribution patterns unique to each stage
      of pressure ulcer can be identified. It is anticipated that 40 patients who meet the
      inclusion criteria and distribution of pressure ulcer staging will be enrolled within one
      year of the start date of this study.

      The investigators are planning a study of a continuous response variable from independent
      control and experimental subjects with 1 control(s) per experimental subject. It is estimated
      that the response within each subject group will be normally distributed with standard
      deviation 25. If the true difference in the experimental and control means is 35, the
      investigators will need to study 9 experimental subjects and 9 control subjects to be able to
      reject the null hypothesis that the population means of the experimental and control groups
      are equal with probability (power) 0.8. The Type I error probability associated with this
      test of this null hypothesis is 0.05.
observational model: Case-Only
time perspective: Prospective
measure: Difference in temperature between a Stage I, Stage 2, Stage 3 and Stage 4 decubitus pressure ulcer as measured by using the thermal imaging camera.
time frame: Up to one year
description: Each subject will receive one temperature measurement during inpatient status of the decubitus pressure ulcer using the thermal imaging camera.
arm group label: Stage I Pressure Ulcer
description: Ten patients with a Stage I decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.
arm group label: Stage II Pressure Ulcer
description: Ten patients with a Stage II decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.
arm group label: Stage III Pressure Ulcer
description: Ten patients with a Stage III decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.
arm group label: Stage IV Pressure Ulcer
description: Ten patients with a Stage IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.
intervention type: Device
intervention name: Thermal imaging
description: Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.
arm group label: Stage I Pressure Ulcer
arm group label: Stage II Pressure Ulcer
arm group label: Stage III Pressure Ulcer
arm group label: Stage IV Pressure Ulcer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jacob T Carlson, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer
sharing ipd: Undecided