<?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>IRCT20180514039657N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-26</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of taurine in diabetic foot ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effects of taurine supplementation on wound healing and metabolic status in patients with diabetic foot ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39239</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to each groups will be done by random block method using block of size 6. Random numbers will be generated randomly by random allocation software. In order to ensure that the selection bias does not occur, the allocation method will be used to allocate a unique code to each patient, Blinding description: In this double blind study the jars containing the capsules will be the same and neither the patients nor researchers know which capsules are being received. In fact, a third person who knows the contents of the jars distributes them among the participants. The shape and size of the capsules are similar in both groups, while their content is different.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetic Foot Ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 25 patients with diabetic foot ulcers take one 500 mg thorium capsule three times per day (1500 mg daily) for 30 days. To control the correct use of pills, cans are available to patients every two weeks and the number of capsules consumed. Intervention 2: Control group: 25 diabetic foot ulcers use a 500 mg starch capsule three times per day (1500 mg daily) for 30 days. To control the correct use of capsules, cans are available to patients every two weeks and the number of capsules consumed.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is it is not the objective of this study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masih Namjoonia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amaniyeh - Palestine Street - Razi Hospital</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6196514941</zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>masih.namjoo@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arman Shahriari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amaniyeh - Palestine Street - Razi Hospital</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6196514941</zip>
        <telephone>+98 61 3333 3050</telephone>
        <email>shahriari-a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetic foot ulcer grade 3 based on Wagner-Meggitt's benchmark
More than 5 years of illness
Patients with type 2 diabetes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The use of alternative therapies, including hormones or vitamin supplements
Pregnant or lactating women
Chronic kidney disease
Chronic liver disease
Chronic Pulmonary Disease
Chronic or acute inflammatory diseases
Heart valve disease
Short Bowel Syndrome
Allergy
Patients with low immune system (autoimmune)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetic ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 25 patients with diabetic foot ulcers take one 500 mg thorium capsule three times per day (1500 mg daily) for 30 days. To control the correct use of pills, cans are available to patients every two weeks and the number of capsules consumed.</i_keyword>
      <i_keyword>Control group: 25 diabetic foot ulcers use a 500 mg starch capsule three times per day (1500 mg daily) for 30 days. To control the correct use of capsules, cans are available to patients every two weeks and the number of capsules consumed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting insulin. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Serum triglyceride. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>LDL-C. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>HDL-C. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>Fasting Blood Glucose. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: The beginning and end of the study. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Fructosamine. Timepoint: The beginning and end of the study. Method of measurement: enzymatic method.</prim_outcome>
      <prim_outcome>Nitric Oxide. Timepoint: The beginning and end of the study. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Oxidized glutathione. Timepoint: The beginning and end of the study. Method of measurement: Spectrophotometry.</prim_outcome>
      <prim_outcome>Wound healing. Timepoint: The beginning and end of the study. Method of measurement: Wagner-Meggitt’s classification.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: The beginning and end of the study. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: The beginning and end of the study. Method of measurement: weight (kg) divided to height square.</sec_outcome>
      <sec_outcome>Systolic Blood Pressure. Timepoint: The beginning and end of the study. Method of measurement: Measuring blood pressure.</sec_outcome>
      <sec_outcome>Diastolic Blood Pressure. Timepoint: The beginning and end of the study. Method of measurement: Measuring blood pressure.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-13</approval_date>
        <contact_name>Ethics committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
