<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/NCT02228629</url>
  </required_header>
  <id_info>
    <org_study_id>21391</org_study_id>
    <nct_id>NCT02228629</nct_id>
  </id_info>
  <brief_title>Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study</brief_title>
  <official_title>Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Foot complications are a common and costly problem for subjects with diabetes. Although&#xD;
      Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not&#xD;
      wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such&#xD;
      as flip flops or slippers, that provide little to no protection against injuries. While&#xD;
      proper house shoe is important in the prevention of diabetic foot complications, this area&#xD;
      has not received much attention. The purpose of this pilot study is to assess if CrocsRx&#xD;
      Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles,&#xD;
      and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to&#xD;
      conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design&#xD;
      will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with&#xD;
      the order of shoes randomized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs</measure>
    <time_frame>At visit 1.</time_frame>
    <description>In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Typical house shoe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject's typical shoes worn in and around home</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CrocsRx Medical Silver cloud clogs</intervention_name>
    <arm_group_label>Typical house shoe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between the ages of 21 and 75 (inclusive)&#xD;
&#xD;
          -  Documented type 1 or type 2 diabetes mellitus&#xD;
&#xD;
          -  Demonstrated abnormal foot biomechanics by the presence of intractable plantar&#xD;
             keratoma (IPK) beneath metatarsal heads or hallux&#xD;
&#xD;
          -  Participants with and without signs of peripheral neuropathy (unable to perceive a 10&#xD;
             gram monofilament or vibration perception threshold (VPT &gt; 25 Volts)&#xD;
&#xD;
          -  Able to walk independently without the use of walking aids (cane, crutches, or walker)&#xD;
&#xD;
          -  Able to speak and understand English&#xD;
&#xD;
          -  Able to understand the information in the consent form and willing and able to sign&#xD;
             the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of lower limb amputations (excluding toe amputations)&#xD;
&#xD;
          -  Presence of cutaneous ulceration in the lower extremity&#xD;
&#xD;
          -  History of or active Charcot neuroarthropathy of either foot&#xD;
&#xD;
          -  Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or&#xD;
             gangrene)&#xD;
&#xD;
          -  End stage kidney disease requiring hemodialysis, stroke, or widespread malignant&#xD;
             disease&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Not willing or able to make the required follow-up visits&#xD;
&#xD;
          -  Insufficient (corrected) vision to complete the questionnaire&#xD;
&#xD;
          -  Unable to fit into available shoe sizes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jinsup Song</last_name>
    <phone>215-625-5369</phone>
    <email>jsong@temple.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gait Study Center at the Temple University School of Podiatric Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinsup Song, D.P.M., Ph.D.</last_name>
      <phone>215-625-5369</phone>
      <email>jsong@temple.edu</email>
    </contact>
    <investigator>
      <last_name>Jinsup Song, D.P.M., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>May 12, 2015</last_update_submitted>
  <last_update_submitted_qc>May 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Temple University</investigator_affiliation>
    <investigator_full_name>Jinsup Song</investigator_full_name>
    <investigator_title>Director, Gait Study Center</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Foot complications</keyword>
  <keyword>plantar keratoma</keyword>
  <keyword>plantar pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_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/NCT02228629
org study id: 21391
nct id: NCT02228629
lead sponsor: 
has dmc: No
Foot complications are a common and costly problem for subjects with diabetes. Although
      Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not
      wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such
      as flip flops or slippers, that provide little to no protection against injuries. While
      proper house shoe is important in the prevention of diabetic foot complications, this area
      has not received much attention. The purpose of this pilot study is to assess if CrocsRx
      Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles,
      and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to
      conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design
      will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with
      the order of shoes randomized.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
time frame: At visit 1.
description: In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.
arm group label: Typical house shoe
arm group type: Experimental
description: Subject's typical shoes worn in and around home
intervention type: Device
intervention name: CrocsRx Medical Silver cloud clogs
arm group label: Typical house shoe
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jinsup Song
phone: 215-625-5369
email: jsong@temple.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Temple University
investigator full name: Jinsup Song
investigator title: Director, Gait Study Center
mesh term: Diabetes Mellitus