<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20150531022500N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Empowerment of Type 2 Diabetic Patients on Prevention of Diabetic Foot</public_title>
      <acronym></acronym>
      <scientific_title>Empowerment of Type 2 Diabetic Patients Visiting Fuladshahr Diabetes Clinics for Prevention of Diabetic Foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32670</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Block randomized.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experiment group participated in the Foot Care Principles program that was designed based on empowerment strategies. Intervention was made through lectures, practically doing feet examination and special feet exercises, playing films, practicing, group discussion, question and answer, providing educational pamphlets and CDs. Also, individual counseling about foot care with the presence of a doctor and diabetes expert, and psychological counseling with a mental health professional was provided in the clinic; and suitable socks for diabetic foot prevention were distributed among experiment group.Considering the sample’s size and the necessity of grouping the subjects in order to reach more efficacy, the patients were divided into four groups of 13. The duration of each session was about 40-50 minutes. For each of the subgroups, four sessions of empowerment were held on a weekly and regular basis. According to this program, empowerment should be carried out in four steps which are presented in this study in four sessions as follows: the first session included general introduction of diabetes, its mechanism, and complications; the second session was dedicated to the definition of the diabetic foot, its types, etiology, the identification of at-risk foot, risk factors and warning signs; the third session included the description of foot care principles (daily foot examinations, nail care and foot skin care measures, appropriate footwear [shoes and socks] selection criteria, and special foot exercises); and, the forth session included stress management and providing solutions to overcome issues related to foot care. Intervention 2: Control group: During this period, the control group was receiving the routine services of the clinic.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farbod Ebadi fardazar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8860 4817</telephone>
        <email>dr-febadi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farbod Ebadi fardazar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8860 4817</telephone>
        <email>dr-febadi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having type 2 diabetes based on diagnosis of an endocrinologist
Absence of diabetic foot
Having diabetic patient records in the diabetes clinics
Absence of other chronic diseases
Willingness to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other chronic diseases
No referral to diabetes clinics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z86.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of diabetic foot ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experiment group participated in the Foot Care Principles program that was designed based on empowerment strategies. Intervention was made through lectures, practically doing feet examination and special feet exercises, playing films, practicing, group discussion, question and answer, providing educational pamphlets and CDs. Also, individual counseling about foot care with the presence of a doctor and diabetes expert, and psychological counseling with a mental health professional was provided in the clinic; and suitable socks for diabetic foot prevention were distributed among experiment group.Considering the sample’s size and the necessity of grouping the subjects in order to reach more efficacy, the patients were divided into four groups of 13. The duration of each session was about 40-50 minutes. For each of the subgroups, four sessions of empowerment were held on a weekly and regular basis. According to this program, empowerment should be carried out in four steps which are presented in this study in four sessions as follows: the first session included general introduction of diabetes, its mechanism, and complications; the second session was dedicated to the definition of the diabetic foot, its types, etiology, the identification of at-risk foot, risk factors and warning signs; the third session included the description of foot care principles (daily foot examinations, nail care and foot skin care measures, appropriate footwear [shoes and socks] selection criteria, and special foot exercises); and, the forth session included stress management and providing solutions to overcome issues related to foot care.</i_keyword>
      <i_keyword>Control group: During this period, the control group was receiving the routine services of the clinic</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perevention of Diabetic Foot. Timepoint: Before the intervention,One month and three months after the implementation of the program. Method of measurement: Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Empowerment. Timepoint: Before the intervention,One month and three months after the implementation of the program. Method of measurement: Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
