<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/NCT04444375</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/71494</org_study_id>
    <nct_id>NCT04444375</nct_id>
  </id_info>
  <brief_title>Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus</brief_title>
  <official_title>Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suleyman Demirel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suleyman Demirel University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common&#xD;
      risk factors for plantar pain and related disability. The aim of our study was to evaluate&#xD;
      the relationship between plantar pain, balance and foot function in diabetic DM patients has&#xD;
      with different BMI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)</measure>
    <time_frame>6 months</time_frame>
    <description>balance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot Function Index</measure>
    <time_frame>6 months</time_frame>
    <description>Foot Function Index of 23 items, and evaluates the pain, disability and activity limitation. The each of the pain and insufficiency subscales consist of 9 items and the activity limitation subscale includes 5 items. Patients score their foot pain level with Visual Analogue Scale (VAS) in various situations during the last 1 week. To calculate the scores of the index, the score of each item are summed, then divided by possible the maximum score can be obtained from the FFI. Higher scores indicate greater pain, disability and activity limitation level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Manchester Foot Pain and Disability Index</measure>
    <time_frame>6 months</time_frame>
    <description>Manchester Foot Pain and Disability Index consists of 4 subsections including 9 questions for inadequacy, 5 questions for pain, 3 questions for concern and 2 questions for difficulty. Each item is scored between 0-2. The total score is calculated by summing the scores from all items. Higher scores indicate worse health situation.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>obese, non-obese</arm_group_label>
    <description>obese and non-obese diabetic patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>balance test</intervention_name>
    <description>balance test</description>
    <arm_group_label>obese, non-obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetes Mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having plantar pain&#xD;
&#xD;
          -  and no change in BMI by more than 10% for at least 3 months&#xD;
&#xD;
          -  being volunteer to participate to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having musculoskeletal surgery for foot&#xD;
&#xD;
          -  having neurological, orthopedic, and cardiovascular diseases&#xD;
&#xD;
          -  vision and hearing problems that may cause balance disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet Duray</last_name>
    <role>Principal Investigator</role>
    <affiliation>Suleyman Demirel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mehmet Duray</name>
      <address>
        <city>Isparta</city>
        <zip>32200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suleyman Demirel University</investigator_affiliation>
    <investigator_full_name>Mehmet Duray</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>plantar pain</keyword>
  <keyword>body mass index</keyword>
  <keyword>obesity</keyword>
  <keyword>balance</keyword>
  <keyword>foot pain</keyword>
  <keyword>disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04444375
org study id: 60116787-020/71494
nct id: NCT04444375
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common
      risk factors for plantar pain and related disability. The aim of our study was to evaluate
      the relationship between plantar pain, balance and foot function in diabetic DM patients has
      with different BMI.
observational model: Other
time perspective: Prospective
measure: the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)
time frame: 6 months
description: balance
measure: Foot Function Index
time frame: 6 months
description: Foot Function Index of 23 items, and evaluates the pain, disability and activity limitation. The each of the pain and insufficiency subscales consist of 9 items and the activity limitation subscale includes 5 items. Patients score their foot pain level with Visual Analogue Scale (VAS) in various situations during the last 1 week. To calculate the scores of the index, the score of each item are summed, then divided by possible the maximum score can be obtained from the FFI. Higher scores indicate greater pain, disability and activity limitation level.
measure: Manchester Foot Pain and Disability Index
time frame: 6 months
description: Manchester Foot Pain and Disability Index consists of 4 subsections including 9 questions for inadequacy, 5 questions for pain, 3 questions for concern and 2 questions for difficulty. Each item is scored between 0-2. The total score is calculated by summing the scores from all items. Higher scores indicate worse health situation.
arm group label: obese, non-obese
description: obese and non-obese diabetic patients
intervention type: Diagnostic Test
intervention name: balance test
description: balance test
arm group label: obese, non-obese
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 64 Years
healthy volunteers: No
last name: Mehmet Duray
role: Principal Investigator
affiliation: Suleyman Demirel University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Suleyman Demirel University
investigator full name: Mehmet Duray
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
sharing ipd: No