<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/NCT02233179</url>
  </required_header>
  <id_info>
    <org_study_id>0900000701</org_study_id>
    <nct_id>NCT02233179</nct_id>
  </id_info>
  <brief_title>The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes</brief_title>
  <official_title>Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qatar National Research Foundation, Qatar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to explore the association between activities of daily living (&#xD;
      measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an&#xD;
      exploratory study, there was no study hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes patients with active foot ulcers were recruited and monitored for activities of&#xD;
      daily living while wearing an offloading device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound size</measure>
    <time_frame>12 weeks</time_frame>
    <description>Wound size was measured every week for 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Physical Activities</measure>
    <time_frame>12 weeks</time_frame>
    <description>Recorded using a body-worn sensor and measured every 4 weeks for 2 days.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>Removable Cast Walker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An offloading device that can be removed by the patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irremovable Cast Walker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Removable cast walker</intervention_name>
    <description>Offloading device that can be removed by patients.</description>
    <arm_group_label>Removable Cast Walker</arm_group_label>
    <other_name>Cast walker from Ossur, Reykjavik, Iceland</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Irremovable cast walker</intervention_name>
    <description>Offloading device that cannot be removed by patients.</description>
    <arm_group_label>Irremovable Cast Walker</arm_group_label>
    <other_name>Cast walker from Ossur, Reykjavik, Iceland</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 or older with non-infected, non-ischemic foot ulcers&#xD;
&#xD;
          -  active neuropathic foot ulcer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major foot amputation&#xD;
&#xD;
          -  active Charcot arthropathy&#xD;
&#xD;
          -  ankle brachial index of 0.5 or less&#xD;
&#xD;
          -  history of substance abuse within 6 months&#xD;
&#xD;
          -  inability to walk 20m&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>37 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David G Armstrong, DPM, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic foot ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calpastatin</mesh_term>
  </intervention_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/NCT02233179
org study id: 0900000701
nct id: NCT02233179
lead sponsor: 
collaborator: 
has dmc: No
The aim of the study was to explore the association between activities of daily living (
      measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an
      exploratory study, there was no study hypothesis.
Diabetes patients with active foot ulcers were recruited and monitored for activities of
      daily living while wearing an offloading device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Wound size
time frame: 12 weeks
description: Wound size was measured every week for 12 weeks
measure: Daily Physical Activities
time frame: 12 weeks
description: Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
arm group label: Removable Cast Walker
arm group type: Experimental
description: An offloading device that can be removed by the patients
arm group label: Irremovable Cast Walker
arm group type: Active Comparator
description: A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
intervention type: Device
intervention name: Removable cast walker
description: Offloading device that can be removed by patients.
arm group label: Removable Cast Walker
other name: Cast walker from Ossur, Reykjavik, Iceland
intervention type: Device
intervention name: Irremovable cast walker
description: Offloading device that cannot be removed by patients.
arm group label: Irremovable Cast Walker
other name: Cast walker from Ossur, Reykjavik, Iceland
criteria: 
gender: All
minimum age: 37 Years
maximum age: 68 Years
healthy volunteers: No
last name: David G Armstrong, DPM, MD, PhD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Calpastatin