<?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>IRCT20181012041317N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-05</date_registration>
      <primary_sponsor>Shahid beheshti university</primary_sponsor>
      <public_title>The effect of atmospheric pressure cold plasma in patients with diabetic foot ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of atmospheric pressure plasma and common treatment in diabetic patients with foot ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34479</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software, Blinding description: The doctor and the patient are unaware of the grouping, and only the plasma radiation expert knows.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Foot Ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study , plasma torch will be used as the source of helium gas jet plasma. The plasma is  created in 2 days a week, and each time for 5 minutes on the wound will be directly exposed. Intervention 2: Control group: In this group only standard wound care treatments such as debridement, dressing, antibiotic administration, and patient education, and no plasma radiation, will be used.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data collected for the primary and secondary outcome measurements .

When:
startting 9 month after publication until 5 years later

To whom:
For researchers working in academic and scientific institutions

Conditions:
Use of data and documentation is not allowed in any article, thesis, etc.

Where to obtain:
The applicant for documentation can be contacted by email with person responsible for scientific inquiries and person responsible for general inquiries . 
person responsible for scientific inquiries : Dr. Hamid Reza Mahmoudi
                                                                                      hr_mahmoody@yahoo.com
person responsible for general inquiries : shirin samsavar
shirinsamsavar@gmail.com

How to obtain:
By sending an email, it can receive data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin samsavar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjou Blvd , District , Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 4017</telephone>
        <email>shirinsamsavar@gmail.com</email>
        <affiliation>Shahid beheshti university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DR . Hamid-reza mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Skin hospital, Razi Ave., Vahdate eslami Ave., Hafez St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1199663911</zip>
        <telephone>+98 21 5561 8989</telephone>
        <email>hr_mahmoody@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes
Has diabetic ulcer size (1-30) cm2
Wound do not have more than 2 years of age.
Hb1Ac &lt; 10%
Do not have bone infection
Patient over 18 years of age</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with addiction or alcohol abuse
Patients with psychological problems or dissatisfaction with the company in the study
Patients with diabetic nephropathy
Localized necrosis /Gangrene
Hb1Ac &gt; 10%</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with peripheral circulatory complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study , plasma torch will be used as the source of helium gas jet plasma. The plasma is  created in 2 days a week, and each time for 5 minutes on the wound will be directly exposed.</i_keyword>
      <i_keyword>Control group: In this group only standard wound care treatments such as debridement, dressing, antibiotic administration, and patient education, and no plasma radiation, will be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound area. Timepoint: After selecting the patient during the 12 sessions (weekly 2 sessions) in the first session (before the treatment) and the end of session 6 and 12, the area of the wound is checked. Method of measurement: Take digital photo with ruler - Push score - Calculate area with imagej software.</prim_outcome>
      <prim_outcome>Exudate levels. Timepoint: At the first session (before treatment) and the end of session 6 and 12 , a microbial culture of the wound secretions is performed. Method of measurement: with standard method swap - Push score.</prim_outcome>
      <prim_outcome>Type of wound tissue. Timepoint: The first session (before treatment) and the end of session 6 and 12 are checked. Method of measurement: Take digital photo - Push score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before treatment - the end of treatment - 8 weeks after the end of treatment. Method of measurement: Diabetes Quality of Life (DQOL) Questionnaire.</sec_outcome>
      <sec_outcome>Side effects of cold plasma radiation on the patient. Timepoint: During and after radiation of the plasma. Method of measurement: Ask the patient about possible symptoms and see the wound's position.</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>Shahid beheshti university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina st. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
