<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/NCT04400344</url>
  </required_header>
  <id_info>
    <org_study_id>A20-018-682</org_study_id>
    <nct_id>NCT04400344</nct_id>
  </id_info>
  <brief_title>Approaches to Foot Complication Prevention: A Survey of Diabetes Educators</brief_title>
  <official_title>Approaches to Foot Complication Prevention: A Survey of Diabetes Educators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Podimetrics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Association of Diabetes Educators</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Podimetrics, Inc.</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>
      The purpose of the survey is to assess the knowledge base, role in management, and resources&#xD;
      available to diabetes educators regarding foot complication prevention within a variety of&#xD;
      healthcare settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Podimetrics is a care management company with a temperature-based foot monitoring solution to&#xD;
      help prevent diabetic foot ulcers, one of the most debilitating and costly complications of&#xD;
      diabetes.&#xD;
&#xD;
      Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines&#xD;
      including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to&#xD;
      better understand the degree to which diabetic foot care and prevention is incorporated into&#xD;
      the diabetes education curriculum. To what extent are these topics discussed between diabetes&#xD;
      educators and the patients they interact with? And how comfortable are educators in&#xD;
      discussing these topics?&#xD;
&#xD;
      To gain insight into these questions Podimetrics researchers have designed an online&#xD;
      questionnaire survey for completion by AADE members. The general purpose of the survey is to&#xD;
      assess the knowledge base, role in management, and resources available to diabetes educators&#xD;
      regarding foot complication prevention within a variety of healthcare settings.&#xD;
&#xD;
      The specific aim is to collect generalizable data to characterize the current state of&#xD;
      diabetic foot education and identify any gaps in knowledge that may be present. Furthermore,&#xD;
      if it is found that educators are lacking important knowledge which supports ample diabetic&#xD;
      foot health education, approaches to bridge these gaps may be suggested through published&#xD;
      recommendations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Anticipated">May 13, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 13, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Current state of diabetic foot care education and knowledge base among diabetic educators</measure>
    <time_frame>One year</time_frame>
    <description>Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Foot Ulcer, Diabetic</condition>
  <arm_group>
    <arm_group_label>Survey Respondents</arm_group_label>
    <description>Respondents are members of the American Association of Diabetes Educators recruited via an introductory email sent out by the AADE on behalf of Podimetrics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Survey Respondents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Respondents are members of the American Association of Diabetes Educators (AADE) recruited&#xD;
        via an introductory email sent out by the AADE on behalf of Podimetrics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Association of Diabetes Educators (AADE) member with accurate email address&#xD;
             on file with the AADE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AADE member with an inability to read English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Podimetrics,Inc.</name>
      <address>
        <city>Somerville</city>
        <state>Massachusetts</state>
        <zip>02144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot</keyword>
  <keyword>Ulcer</keyword>
  <keyword>Care recommendation</keyword>
  <keyword>Foot Diseases</keyword>
  <keyword>Diabetic Neuropathies</keyword>
  <keyword>Diabetes Education</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Diabetes Educator</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Diabetes Complication</keyword>
  <keyword>Care and treatment</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>To protect the respondent's identity, respondent name and email address will not be recorded within the survey results. No demographic data other than relevant profession, work environment, and number of years as a certified educator will be collected. Additionally, the AADE will not share respondent's name or email addresses with Podimetrics, and the AADE will not have access to the individual survey results, effectively detaching individual results from respondents' identities.</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/NCT04400344
org study id: A20-018-682
nct id: NCT04400344
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the survey is to assess the knowledge base, role in management, and resources
      available to diabetes educators regarding foot complication prevention within a variety of
      healthcare settings.
Podimetrics is a care management company with a temperature-based foot monitoring solution to
      help prevent diabetic foot ulcers, one of the most debilitating and costly complications of
      diabetes.

      Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines
      including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to
      better understand the degree to which diabetic foot care and prevention is incorporated into
      the diabetes education curriculum. To what extent are these topics discussed between diabetes
      educators and the patients they interact with? And how comfortable are educators in
      discussing these topics?

      To gain insight into these questions Podimetrics researchers have designed an online
      questionnaire survey for completion by AADE members. The general purpose of the survey is to
      assess the knowledge base, role in management, and resources available to diabetes educators
      regarding foot complication prevention within a variety of healthcare settings.

      The specific aim is to collect generalizable data to characterize the current state of
      diabetic foot education and identify any gaps in knowledge that may be present. Furthermore,
      if it is found that educators are lacking important knowledge which supports ample diabetic
      foot health education, approaches to bridge these gaps may be suggested through published
      recommendations.
observational model: Cohort
time perspective: Cross-Sectional
measure: Current state of diabetic foot care education and knowledge base among diabetic educators
time frame: One year
description: Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
arm group label: Survey Respondents
description: Respondents are members of the American Association of Diabetes Educators recruited via an introductory email sent out by the AADE on behalf of Podimetrics.
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Survey Respondents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No
ipd description: To protect the respondent's identity, respondent name and email address will not be recorded within the survey results. No demographic data other than relevant profession, work environment, and number of years as a certified educator will be collected. Additionally, the AADE will not share respondent's name or email addresses with Podimetrics, and the AADE will not have access to the individual survey results, effectively detaching individual results from respondents' identities.