<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/NCT04480801</url>
  </required_header>
  <id_info>
    <org_study_id>FOzkal</org_study_id>
    <nct_id>NCT04480801</nct_id>
  </id_info>
  <brief_title>The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer</brief_title>
  <official_title>The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatma Özkal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Necmettin Erbakan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Necmettin Erbakan University</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 study was planned as a prospective randomized controlled clinical trial to determine the&#xD;
      effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II&#xD;
      Diabetes Mellitus (DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes Mellitus (DM) is a chronic disease caused by insufficient production of insulin&#xD;
      hormone in the pancreas gland or inefficient use of the insulin produced. Diabetic neuropathy&#xD;
      that occurs in 60-70% of patients with DM is reported to be the most important factor&#xD;
      increasing the risk of diabetic foot. Determining risk factors in diabetic foot and&#xD;
      attempting to eliminate or mitigate these factors have been found to be a simple, inexpensive&#xD;
      and evidence-based tool that can be used at home by patients. This study will contribute to&#xD;
      the current literature on the effectiveness of thermal assessment in preventing diabetic foot&#xD;
      ulcers. The study was planned as a prospective randomized controlled clinical trial to&#xD;
      determine the effect of thermal assessment on preventing diabetic foot ulcers in patients&#xD;
      with Type II Diabetes Mellitus (DM). For the sample of the study, compared to those with&#xD;
      thermal evaluation, the study reported that the probability of developing diabetic feet was&#xD;
      10.3 times higher than those without thermal evaluation program, 48 patients (thermal&#xD;
      evaluation group: 24 people; control group: 24 people) were included in the study. It was&#xD;
      decided that 30 patients were lost during data collection and 35 patients were included in&#xD;
      each study group and the study was completed with a total of 70 patients. The patients&#xD;
      included in the study will be assigned to the experimental group (thermal evaluation group)&#xD;
      and control group by block randomization method according to the randomization list in a&#xD;
      ratio of 1: 1. In the study, block randomization was performed by a statistician based on the&#xD;
      current disease year (diabetes year) and the degree of diabetic foot risk.&#xD;
&#xD;
      For the implementation of the study, permission was obtained from the ethics committee of&#xD;
      Necmettin Erbakan University Meram Medical Faculty, Non-Drug and Medical Device Research&#xD;
      Ethics Committee, and work permit was obtained from Necmettin Erbakan University Meram&#xD;
      Medical Faculty Hospital Chief Physician. Patients included in the study sample will be&#xD;
      informed before the study that the purpose of the study and participation in the study is in&#xD;
      line with the principle of volunteering, and &quot;Informing and Consent of Volunteers Consent&#xD;
      Form&quot; will be signed.&#xD;
&#xD;
      Data collection tools;&#xD;
&#xD;
        -  Personal Information Form,&#xD;
&#xD;
        -  Chart to Record Diabetic Foot Risk Assessment Findings&#xD;
&#xD;
        -  Structured Daily Foot Care Form,&#xD;
&#xD;
        -  Evaluation Charts to be Given to Patients During Discharge&#xD;
&#xD;
      Independent variables&#xD;
&#xD;
        -  Identifying features of patients&#xD;
&#xD;
        -  Features of patients associated with Diabetes Mellitus and its treatment&#xD;
&#xD;
        -  Diabetic foot risk assessment results&#xD;
&#xD;
        -  Foot care initiatives&#xD;
&#xD;
      Dependent Variables&#xD;
&#xD;
      - Development of diabetic foot ulcer&#xD;
&#xD;
      Evaluation of the Data&#xD;
&#xD;
      In the evaluation of the descriptive data obtained from the research, number, percentage,&#xD;
      average and standard deviation will be used; The conformity of the data to normal&#xD;
      distribution will be determined by Kolmogorov-Smirnov test and normal distribution curve,&#xD;
      Skewness and Kurtosis test, and when the data show normal distribution, parametric tests will&#xD;
      be used, and nonparametric tests will be used in the analysis of data that do not conform to&#xD;
      the normal distribution. Significance will be evaluated within the confidence interval of&#xD;
      95%, p &lt;0.05 will be taken.&#xD;
&#xD;
      İmplementation of the research&#xD;
&#xD;
      After vascular evaluation, neuropathy evaluation, and physical evaluation of the foot,&#xD;
      individuals with a diagnosis of type 2 diabetes aged 18 and over will be formed the sample&#xD;
      group. Once the sample group is determined, participants will be randomly assigned to the&#xD;
      experimental and control groups.&#xD;
&#xD;
      Participants in the experimental group will be given foot care in the clinic and will be&#xD;
      taught to the patient and / or their relatives. The foot care video will be uploaded to the&#xD;
      patient and / or relative's phone. Thermal evaluation will be done. The application of the&#xD;
      thermal evaluation, the foot areas to be applied and how to record the results of the&#xD;
      application will be taught to the patient and / or their relatives. In addition, the thermal&#xD;
      evaluation video will be uploaded to the phone of the patient and / or their relative. While&#xD;
      the participants in the experimental group were discharged; Blood glucose monitoring chart,&#xD;
      Checklist to record foot care interventions, Thermal evaluation registration form, Daily step&#xD;
      number registration form will be provided and participants will be invited to check every 2&#xD;
      months.&#xD;
&#xD;
      Participants in the control group will be given foot care in the clinic and will be taught to&#xD;
      the patient and / or their relatives. The foot care video will be uploaded to the patient and&#xD;
      / or relative's phone.While the participants in the control group were discharged; Blood&#xD;
      glucose monitoring chart, Checklist to record foot care interventions will be provided and&#xD;
      participants will be invited to check every 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 15, 2022</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>
    <intervention_model_description>prospective randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients developing a foot ulcer</measure>
    <time_frame>2 months after the first assessment</time_frame>
    <description>There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in blood sugar values</measure>
    <time_frame>2-month intervals until 1-year follow-up</time_frame>
    <description>Changes in blood sugar levels in both groups for 12 months every 2 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in foot care practices</measure>
    <time_frame>2-month intervals until 1-year follow-up</time_frame>
    <description>Change in foot care practices for 12 months every 2 months in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>thermal evaluation and foot care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>foot care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thermal Evaluation and Foot Care</intervention_name>
    <description>Participants in the experimental group will be given foot care and thermal evaluation in the clinic and will be taught to the patient and / or their relatives. Thermal evaluation and foot care video will be uploaded to the patient and / or relative's phone.</description>
    <arm_group_label>thermal evaluation and foot care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foot Care</intervention_name>
    <description>Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. Foot care video will be uploaded to the patient and / or relative's phone.</description>
    <arm_group_label>foot care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and over&#xD;
&#xD;
          -  Volunteer&#xD;
&#xD;
          -  Sign the informed consent form&#xD;
&#xD;
          -  Diagnosed with type II Diabetes Mellitus&#xD;
&#xD;
          -  No diabetic foot ulcer&#xD;
&#xD;
          -  Patients with no foot or toe amputation will be admitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not sign the informed consent form&#xD;
&#xD;
          -  Without a smart phone&#xD;
&#xD;
          -  Diagnosed with Type I Diabetes Mellitus,&#xD;
&#xD;
          -  Patients with diabetic foot ulcers&#xD;
&#xD;
          -  With ankle / arm index &lt;0.9 and &gt;1.30,&#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>FATMA ÖZKAL</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Serpil YÜKSEL, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necmettin Erbakan University</name>
      <address>
        <city>Konya</city>
        <zip>42080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>Fatma Özkal</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>diabetic foot</keyword>
  <keyword>risk factors</keyword>
  <keyword>thermal evaluation</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>Yes</sharing_ipd>
    <ipd_description>Study Protocol</ipd_description>
    <ipd_info_type>Study Protocol</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/NCT04480801
org study id: FOzkal
nct id: NCT04480801
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study was planned as a prospective randomized controlled clinical trial to determine the
      effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II
      Diabetes Mellitus (DM).
Diabetes Mellitus (DM) is a chronic disease caused by insufficient production of insulin
      hormone in the pancreas gland or inefficient use of the insulin produced. Diabetic neuropathy
      that occurs in 60-70% of patients with DM is reported to be the most important factor
      increasing the risk of diabetic foot. Determining risk factors in diabetic foot and
      attempting to eliminate or mitigate these factors have been found to be a simple, inexpensive
      and evidence-based tool that can be used at home by patients. This study will contribute to
      the current literature on the effectiveness of thermal assessment in preventing diabetic foot
      ulcers. The study was planned as a prospective randomized controlled clinical trial to
      determine the effect of thermal assessment on preventing diabetic foot ulcers in patients
      with Type II Diabetes Mellitus (DM). For the sample of the study, compared to those with
      thermal evaluation, the study reported that the probability of developing diabetic feet was
      10.3 times higher than those without thermal evaluation program, 48 patients (thermal
      evaluation group: 24 people; control group: 24 people) were included in the study. It was
      decided that 30 patients were lost during data collection and 35 patients were included in
      each study group and the study was completed with a total of 70 patients. The patients
      included in the study will be assigned to the experimental group (thermal evaluation group)
      and control group by block randomization method according to the randomization list in a
      ratio of 1: 1. In the study, block randomization was performed by a statistician based on the
      current disease year (diabetes year) and the degree of diabetic foot risk.

      For the implementation of the study, permission was obtained from the ethics committee of
      Necmettin Erbakan University Meram Medical Faculty, Non-Drug and Medical Device Research
      Ethics Committee, and work permit was obtained from Necmettin Erbakan University Meram
      Medical Faculty Hospital Chief Physician. Patients included in the study sample will be
      informed before the study that the purpose of the study and participation in the study is in
      line with the principle of volunteering, and "Informing and Consent of Volunteers Consent
      Form" will be signed.

      Data collection tools;

        -  Personal Information Form,

        -  Chart to Record Diabetic Foot Risk Assessment Findings

        -  Structured Daily Foot Care Form,

        -  Evaluation Charts to be Given to Patients During Discharge

      Independent variables

        -  Identifying features of patients

        -  Features of patients associated with Diabetes Mellitus and its treatment

        -  Diabetic foot risk assessment results

        -  Foot care initiatives

      Dependent Variables

      - Development of diabetic foot ulcer

      Evaluation of the Data

      In the evaluation of the descriptive data obtained from the research, number, percentage,
      average and standard deviation will be used; The conformity of the data to normal
      distribution will be determined by Kolmogorov-Smirnov test and normal distribution curve,
      Skewness and Kurtosis test, and when the data show normal distribution, parametric tests will
      be used, and nonparametric tests will be used in the analysis of data that do not conform to
      the normal distribution. Significance will be evaluated within the confidence interval of
      95%, p <0.05 will be taken.

      İmplementation of the research

      After vascular evaluation, neuropathy evaluation, and physical evaluation of the foot,
      individuals with a diagnosis of type 2 diabetes aged 18 and over will be formed the sample
      group. Once the sample group is determined, participants will be randomly assigned to the
      experimental and control groups.

      Participants in the experimental group will be given foot care in the clinic and will be
      taught to the patient and / or their relatives. The foot care video will be uploaded to the
      patient and / or relative's phone. Thermal evaluation will be done. The application of the
      thermal evaluation, the foot areas to be applied and how to record the results of the
      application will be taught to the patient and / or their relatives. In addition, the thermal
      evaluation video will be uploaded to the phone of the patient and / or their relative. While
      the participants in the experimental group were discharged; Blood glucose monitoring chart,
      Checklist to record foot care interventions, Thermal evaluation registration form, Daily step
      number registration form will be provided and participants will be invited to check every 2
      months.

      Participants in the control group will be given foot care in the clinic and will be taught to
      the patient and / or their relatives. The foot care video will be uploaded to the patient and
      / or relative's phone.While the participants in the control group were discharged; Blood
      glucose monitoring chart, Checklist to record foot care interventions will be provided and
      participants will be invited to check every 2 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomized controlled clinical trial
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Percentage of patients developing a foot ulcer
time frame: 2 months after the first assessment
description: There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.
measure: Changes in blood sugar values
time frame: 2-month intervals until 1-year follow-up
description: Changes in blood sugar levels in both groups for 12 months every 2 months
measure: Change in foot care practices
time frame: 2-month intervals until 1-year follow-up
description: Change in foot care practices for 12 months every 2 months in both groups
arm group label: thermal evaluation and foot care
arm group type: Experimental
description: Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months.
arm group label: foot care
arm group type: Other
description: Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.
intervention type: Other
intervention name: Thermal Evaluation and Foot Care
description: Participants in the experimental group will be given foot care and thermal evaluation in the clinic and will be taught to the patient and / or their relatives. Thermal evaluation and foot care video will be uploaded to the patient and / or relative's phone.
arm group label: thermal evaluation and foot care
intervention type: Other
intervention name: Foot Care
description: Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. Foot care video will be uploaded to the patient and / or relative's phone.
arm group label: foot care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: FATMA ÖZKAL
role: Principal Investigator
affiliation: Necmettin Erbakan University
last name: Serpil YÜKSEL, Phd
role: Study Director
affiliation: Necmettin Erbakan University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: Fatma Özkal
investigator title: Lecturer
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: Yes
ipd description: Study Protocol
ipd info type: Study Protocol