xml: <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/NCT05968924</url>
    </required_header>
    <id_info>
      <org_study_id>2023-14915</org_study_id>
      <nct_id>NCT05968924</nct_id>
    </id_info>
    <brief_title>Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology</brief_title>
    <acronym>DFUMAT</acronym>
    <official_title>Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Montefiore Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Podimetrics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Montefiore Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigator team will study the adherence of the participant cohort to a non significant&#xD;
        risk device over a six month period. The device is a foot mat, which can detect changes in&#xD;
        foot temperature that may predict foot ulceration in patients with diabetes mellitus. This&#xD;
        mat, the PodimetricsSmart Mat, is FDA cleared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of&#xD;
        changes in the foot that predict the development of DFU could allow timely intervention to&#xD;
        prevent the limb damage that occurs with advanced DFU.&#xD;
  &#xD;
        Studies have demonstrated that increased temperature in the foot presage the development of&#xD;
        DFU. Temperature changes can accurately be detected by home monitoring devices and predict&#xD;
        impending ulceration. Here the study team will test the uptake of novel foot temperature&#xD;
        monitoring technology for a future intervention study to determine if a home monitoring&#xD;
        device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center&#xD;
        (MMC).&#xD;
  &#xD;
        The investigator team will conduct a longitudinal study to determine the adherence to an FDA&#xD;
        cleared device, Podimetrics, which has been tested in other populations and shown to 1)&#xD;
        decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in&#xD;
        high risk patients with a history of DFU.&#xD;
  &#xD;
        For this study, the study team will identify and enroll patients who are at high risk for&#xD;
        DFU. These participants will be identified from the electronic medical record (EMR).&#xD;
  &#xD;
        After providing informed consent, study participants will receive the foot mat and obtain&#xD;
        training remotely from Podimetrics, which provides a standardized training program.&#xD;
  &#xD;
        Participants briefly stand on the mat daily (20 seconds), and the temperature data is&#xD;
        automatically sent for analysis to Podimetrics to interpret the information. The participants&#xD;
        will be evaluated over a six-month period to measure:&#xD;
  &#xD;
          1. daily use of the technology&#xD;
  &#xD;
          2. Secondary outcomes: occurrence of DFU and use of health care resources.&#xD;
  &#xD;
        Study participants will be contacted every month by the Einstein investigators to assess foot&#xD;
        health. Study participants will be instructed to contact the study team during the study&#xD;
        period to inquire if development of any changes in the foot such as the diagnosis of DFU, or&#xD;
        if a foot cast is required for offloading, or if participants have any concerns about their&#xD;
        feet.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Adherence to use of SmartMat</measure>
      <time_frame>Six months</time_frame>
      <description>Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Use of health care facilities</measure>
      <time_frame>Six months</time_frame>
      <description>Enumerate total number of health care visits (ER, podiatrist, internist, walk in clinic, etc.) (number of visits over total study time) (subject self report)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>High risk DFU</arm_group_label>
      <description>Type 1 or Type 2 diabetes mellitus&#xD;
  Prior history of a healed DFU within 12 months&#xD;
  Subject had at least one outpatient follow up with a provider after diagnosis with a DFU&#xD;
  No active ulcer at the time of enrollment&#xD;
  Male or female, aged &lt;18-75 yrs&gt;&#xD;
  Ambulatory&#xD;
  Provision of signed and dated informed consent form&#xD;
  Stated willingness to comply with all study procedures and availability for the duration of the study&#xD;
  Amputation (not TMA or BKA) allowed</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PodimetricsSmart Mat</intervention_name>
      <description>receive training on stepping on SmartMat each day for 6 months; and step on the mat every day for 6 months; monthly phone calls will be conducted to assess foot health and mat.</description>
      <arm_group_label>High risk DFU</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with diabetes mellitus and history of prior diabetic foot ulcer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Type 1 or Type 2 diabetes mellitus&#xD;
  &#xD;
            2. Prior history of a DFU within 12 months&#xD;
  &#xD;
            3. Subject had at least one outpatient follow up with a provider after diagnosis with DFU&#xD;
  &#xD;
            4. No active ulcer at time of enrollment&#xD;
  &#xD;
            5. Male or female, aged &lt;18-75 yrs&gt;&#xD;
  &#xD;
            6. Ambulatory&#xD;
  &#xD;
            7. Provision of signed and dated informed consent form&#xD;
  &#xD;
            8. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            9. Amputation (not TMA or AKA/BKA) allowed (transmetatarsal, amputation, or above or&#xD;
               below knee)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Active diabetic foot ulcer (DFU) 2. Unable to comply with study requirements. 3. Prior&#xD;
          TMA or AKA/BKA (transmetatarsal, amputation, or above or below knee) amputation)&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Montefiore.Medical Center</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10461</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Johanna P Daily, MD</last_name>
        <phone>617-680-5112</phone>
        <email>johanna.daily@einsteinmed.edu</email>
      </contact>
      <contact_backup>
        <last_name>Alyson Myers, MD</last_name>
        <phone>866-633-8255</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <keyword>Foot Ulcer</keyword>
    <keyword>Prevention</keyword>
    <keyword>Innovation</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968924
  org study id: 2023-14915
  nct id: NCT05968924
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The investigator team will study the adherence of the participant cohort to a non significant
        risk device over a six month period. The device is a foot mat, which can detect changes in
        foot temperature that may predict foot ulceration in patients with diabetes mellitus. This
        mat, the PodimetricsSmart Mat, is FDA cleared.
  Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of
        changes in the foot that predict the development of DFU could allow timely intervention to
        prevent the limb damage that occurs with advanced DFU.
  
        Studies have demonstrated that increased temperature in the foot presage the development of
        DFU. Temperature changes can accurately be detected by home monitoring devices and predict
        impending ulceration. Here the study team will test the uptake of novel foot temperature
        monitoring technology for a future intervention study to determine if a home monitoring
        device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center
        (MMC).
  
        The investigator team will conduct a longitudinal study to determine the adherence to an FDA
        cleared device, Podimetrics, which has been tested in other populations and shown to 1)
        decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in
        high risk patients with a history of DFU.
  
        For this study, the study team will identify and enroll patients who are at high risk for
        DFU. These participants will be identified from the electronic medical record (EMR).
  
        After providing informed consent, study participants will receive the foot mat and obtain
        training remotely from Podimetrics, which provides a standardized training program.
  
        Participants briefly stand on the mat daily (20 seconds), and the temperature data is
        automatically sent for analysis to Podimetrics to interpret the information. The participants
        will be evaluated over a six-month period to measure:
  
          1. daily use of the technology
  
          2. Secondary outcomes: occurrence of DFU and use of health care resources.
  
        Study participants will be contacted every month by the Einstein investigators to assess foot
        health. Study participants will be instructed to contact the study team during the study
        period to inquire if development of any changes in the foot such as the diagnosis of DFU, or
        if a foot cast is required for offloading, or if participants have any concerns about their
        feet.
  observational model: Cohort
  time perspective: Prospective
  measure: Adherence to use of SmartMat
  time frame: Six months
  description: Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months)
  measure: Use of health care facilities
  time frame: Six months
  description: Enumerate total number of health care visits (ER, podiatrist, internist, walk in clinic, etc.) (number of visits over total study time) (subject self report)
  arm group label: High risk DFU
  description: Type 1 or Type 2 diabetes mellitus
  Prior history of a healed DFU within 12 months
  Subject had at least one outpatient follow up with a provider after diagnosis with a DFU
  No active ulcer at the time of enrollment
  Male or female, aged <18-75 yrs>
  Ambulatory
  Provision of signed and dated informed consent form
  Stated willingness to comply with all study procedures and availability for the duration of the study
  Amputation (not TMA or BKA) allowed
  intervention type: Device
  intervention name: PodimetricsSmart Mat
  description: receive training on stepping on SmartMat each day for 6 months; and step on the mat every day for 6 months; monthly phone calls will be conducted to assess foot health and mat.
  arm group label: High risk DFU
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  sharing ipd: No