<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/NCT04402398</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL19_0280</org_study_id>
    <nct_id>NCT04402398</nct_id>
  </id_info>
  <brief_title>Psychometric Properties of a Mobile Application</brief_title>
  <acronym>IMITO</acronym>
  <official_title>Psychometric Properties of a Mobile Application in Pressure Ulcers for Patients With Spinal Cord Injuries (SCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current methods to assess superficial size and area of pressure ulcers are either&#xD;
      time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or&#xD;
      necessitating to touch the patient's skin (using commun rulers).&#xD;
&#xD;
      A free smartphone application (for IOS or Android) has recently been developed to measures&#xD;
      skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A&#xD;
      photograph is taken with the smartphone, the limits of the lesion is then drawn with the&#xD;
      health carers' finger on the phone's screen. The application computes the length, width and&#xD;
      surface of the ulcer.&#xD;
&#xD;
      This technique has not yet been validated, although it has been used to measure various types&#xD;
      of skin lesions.&#xD;
&#xD;
      The objective of this study is to validate this measurement technique on a sample of pressure&#xD;
      ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by&#xD;
      comparison to the currently most frequently used techniques (Transparency Tracings and&#xD;
      ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.&#xD;
&#xD;
      imitoMeasure is a new smartphone application to measure wounds size. The present study&#xD;
      assesses validity of the measure against common measures (ruler-based and transparency&#xD;
      tracings), and the inter- and intra-rater reliability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure</measure>
    <time_frame>immediately upon first assessment of patients</time_frame>
    <description>Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure</measure>
    <time_frame>immediately upon first assessment of patients</time_frame>
    <description>Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inter-rater and intra-rater validity of imitoMeasure</measure>
    <time_frame>immediately upon first assessment of patients</time_frame>
    <description>inter-rater and intra-rater validity of imitoMeasure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of imitoMeasure of length and width of ulcers to ruler-based measures</measure>
    <time_frame>immediately upon first assessment of patients</time_frame>
    <description>Correlation of imitoMeasure of length and width of ulcers to ruler-based measures</description>
  </secondary_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patients, providing consent for study, with complete or incomplete spinal cord&#xD;
        injury, with pressure ulcers requiring hospital follow-up (lesion stade II to IV), followed&#xD;
        at Centre Mutualiste Propara, rehabilitation centre, Montpellier, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  complete or incomplete spinal cord injury, all delays or aetiologies&#xD;
&#xD;
          -  presence of one or more pressure ulcers stade II to IV&#xD;
&#xD;
          -  adults&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  refusal to participate&#xD;
&#xD;
          -  local infection&#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>Isabelle LAFFONT</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uh Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pressure ulcer</keyword>
  <keyword>validity of measures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04402398
org study id: RECHMPL19_0280
nct id: NCT04402398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current methods to assess superficial size and area of pressure ulcers are either
      time-consuming (using Transparency Tracings techniques), costly (computers, softwares), or
      necessitating to touch the patient's skin (using commun rulers).

      A free smartphone application (for IOS or Android) has recently been developed to measures
      skin lesions. It is called imitoMeasure. It does not require any contact with the patient. A
      photograph is taken with the smartphone, the limits of the lesion is then drawn with the
      health carers' finger on the phone's screen. The application computes the length, width and
      surface of the ulcer.

      This technique has not yet been validated, although it has been used to measure various types
      of skin lesions.

      The objective of this study is to validate this measurement technique on a sample of pressure
      ulcer in a population of patients with spinal cord injury (SCI). Reliability is assessed by
      comparison to the currently most frequently used techniques (Transparency Tracings and
      ruler-based), and fiability is assessed by intra-rater and inter-rater correlations.

      imitoMeasure is a new smartphone application to measure wounds size. The present study
      assesses validity of the measure against common measures (ruler-based and transparency
      tracings), and the inter- and intra-rater reliability.
observational model: Cohort
time perspective: Retrospective
measure: Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
time frame: immediately upon first assessment of patients
description: Correlation of imitoMeasure of ulcers' surface to transparency tracing surface measure
measure: Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
time frame: immediately upon first assessment of patients
description: Correlation of imitoMeasure of ulcers' surface to ruler-based surface measure
measure: inter-rater and intra-rater validity of imitoMeasure
time frame: immediately upon first assessment of patients
description: inter-rater and intra-rater validity of imitoMeasure
measure: Correlation of imitoMeasure of length and width of ulcers to ruler-based measures
time frame: immediately upon first assessment of patients
description: Correlation of imitoMeasure of length and width of ulcers to ruler-based measures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle LAFFONT
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: Undecided
ipd description: NC