<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/NCT04460573</url>
  </required_header>
  <id_info>
    <org_study_id>HS-20-00526</org_study_id>
    <nct_id>NCT04460573</nct_id>
  </id_info>
  <brief_title>Smart Boot Use to Measure Offloading Adherence</brief_title>
  <official_title>Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to help people with diabetes who develop neuropathic diabetic&#xD;
      foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of&#xD;
      amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help&#xD;
      their foot heal. Sometimes people don't wear the boot like they are told. The investigators&#xD;
      want to compare three different kinds of diabetic boots to see if they can help make it&#xD;
      easier for people to wear their boots as instructed.&#xD;
&#xD;
      The investigators will look at three groups of participants: the first group will wear a boot&#xD;
      that can't be taken off. The second group will wear a boot that can be taken off, and they&#xD;
      will get counseling about how important it is to follow instructions as to how often and when&#xD;
      to wear the boot. The third group will wear a &quot;smart&quot; boot, which will interact with the&#xD;
      person through a smart watch and smart phone, and give them direct feedback about how they&#xD;
      are doing with following their boot wearing prescription.&#xD;
&#xD;
      The investigators will also be looking at how much physical activity, like walking, the&#xD;
      participants do. And they will compare how well participants sleep and rate their quality of&#xD;
      life in the three different boots. The investigators think that giving participants&#xD;
      information about how much they are wearing their boot using readily available technology&#xD;
      will help them to follow the doctor's directions better, and help their wounds heal faster.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 19, 2021</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective, comparative randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound healing</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent healed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to offloading</measure>
    <time_frame>12 weeks</time_frame>
    <description>Average daily hours of device wear during weight bearing activities, objectively measured using smart boot</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Speed of wound healing</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured as average weekly change in area of wound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by smart boot</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Smart boot irremovable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smart boot removable</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smart boot, removable, without feedback on adherence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smart boot removable+reinforcement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Boot</intervention_name>
    <description>Smart boot in one of three configurations provided to participants</description>
    <arm_group_label>Smart boot irremovable</arm_group_label>
    <arm_group_label>Smart boot removable</arm_group_label>
    <arm_group_label>Smart boot removable+reinforcement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female aged 18 or older&#xD;
&#xD;
          -  Diabetic Foot Ulcer requiring offloading&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wound present for more than one year&#xD;
&#xD;
          -  HbA1c &gt; 12%&#xD;
&#xD;
          -  Ankle Brachial Index (ABI) of index limb is &lt;0.9 and/or they are being considered for&#xD;
             revascularization within the course of the study&#xD;
&#xD;
          -  Ulcer involving bone or tendon&#xD;
&#xD;
          -  Ulcer not caused by diabetes&#xD;
&#xD;
          -  Unable or unwilling to attend prescribed clinic visits&#xD;
&#xD;
          -  Fully confined to a wheelchair&#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>David G Armstrong, DPN, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Surgery, Keck School of Medicine of USC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jason Garcia, BA</last_name>
    <phone>323-680-0196</phone>
    <email>Jason.garcia@med.usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabiola Rodriguez</last_name>
    <phone>323-516-2132</phone>
    <email>fabiola.rodriguez@med.usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rancho Los Amigos National Rehabilitation Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Garcia, BA</last_name>
      <phone>323-680-0196</phone>
      <email>jason.garcia@med.usc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Verdugo Hills Hospital of USC</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Garcia</last_name>
      <phone>323-680-0196</phone>
      <email>jason.garcia@med.usc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clemente Clinical Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Mathis</last_name>
      <phone>323-330-4287</phone>
      <email>scott.mathis@clementeclinical.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Keck Medical Center of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason A Garcia, BA</last_name>
      <phone>323-680-0196</phone>
      <email>jason.garcia@med.usc.edu</email>
    </contact>
    <contact_backup>
      <last_name>BA</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>David Armstrong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individually identifiable data will be deleted or masked before being made available to individuals who are not a part of the study (research staff). Results released will be sufficiently aggregated as to make individual identification of subjects highly unlikely. When individual research subjects are identifiable using substitute unique identifiers (i.e., subject 10) the translation table will be safeguarded from release outside of the study staff.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04460573
org study id: HS-20-00526
nct id: NCT04460573
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to help people with diabetes who develop neuropathic diabetic
      foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of
      amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help
      their foot heal. Sometimes people don't wear the boot like they are told. The investigators
      want to compare three different kinds of diabetic boots to see if they can help make it
      easier for people to wear their boots as instructed.

      The investigators will look at three groups of participants: the first group will wear a boot
      that can't be taken off. The second group will wear a boot that can be taken off, and they
      will get counseling about how important it is to follow instructions as to how often and when
      to wear the boot. The third group will wear a "smart" boot, which will interact with the
      person through a smart watch and smart phone, and give them direct feedback about how they
      are doing with following their boot wearing prescription.

      The investigators will also be looking at how much physical activity, like walking, the
      participants do. And they will compare how well participants sleep and rate their quality of
      life in the three different boots. The investigators think that giving participants
      information about how much they are wearing their boot using readily available technology
      will help them to follow the doctor's directions better, and help their wounds heal faster.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, comparative randomized trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Wound healing
time frame: 12 weeks
description: Percent healed
measure: Adherence to offloading
time frame: 12 weeks
description: Average daily hours of device wear during weight bearing activities, objectively measured using smart boot
measure: Speed of wound healing
time frame: 12 weeks
description: Measured as average weekly change in area of wound
measure: Physical Activity
time frame: 12 weeks
description: Measured by smart boot
arm group label: Smart boot irremovable
arm group type: Active Comparator
description: Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.
arm group label: Smart boot removable
arm group type: Active Comparator
description: Smart boot, removable, without feedback on adherence.
arm group label: Smart boot removable+reinforcement
arm group type: Experimental
description: Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.
intervention type: Device
intervention name: Boot
description: Smart boot in one of three configurations provided to participants
arm group label: Smart boot irremovable
arm group label: Smart boot removable
arm group label: Smart boot removable+reinforcement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David G Armstrong, DPN, MD, PhD
role: Principal Investigator
affiliation: Professor of Surgery, Keck School of Medicine of USC
last name: Jason Garcia, BA
phone: 323-680-0196
email: Jason.garcia@med.usc.edu
last name: Fabiola Rodriguez
phone: 323-516-2132
email: fabiola.rodriguez@med.usc.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: David Armstrong
investigator title: Professor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: Yes
ipd description: Individually identifiable data will be deleted or masked before being made available to individuals who are not a part of the study (research staff). Results released will be sufficiently aggregated as to make individual identification of subjects highly unlikely. When individual research subjects are identifiable using substitute unique identifiers (i.e., subject 10) the translation table will be safeguarded from release outside of the study staff.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)