<?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>IRCT20190708044148N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Oxygen  on Diabetic Foot Ulcer</public_title>
      <acronym></acronym>
      <scientific_title>Study Of  the Effect of Topical Oxygen Therapy on Diabetic Foot Ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40681</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this Study, Kevin Tosing method and simple random assigment method (using red and blue balls, the red ball representing the control group and the blue balloon representing the intervention group) will be used, Blinding description: Intervention will take place on both day and day and on shifts in the morning and evening. Patients or their families were unaware of the intervention, so this is a one-blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>DIABETIC FOOT ULCER.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the ulcer was washed three times with sterile normal saline, and then a high pressure oxygenated portion of 10 liters per minute was placed on the document for 20 minutes. At last, the wound was dressed with enough gas. This case is repeated three times a day.Document for 20 minute: Based on the study by Eric Blackman et al. (2010), a study of treatment of severe diabetic foot ulcers with topical oxygen: a prospective controlled study at the Ontario Wound Center Clinic in Canada on 28 diabetic patients who had two The intervention and control groups were divided into two groups of silver bandages at least twice a week and in the intervention group 60 minutes of oxygen daily with topical wound treatment oxygen therapy (TWO2) given for 90 days from Monday to Friday. Were treated. Therefore, treatment was performed in 60 minutes and in three alternating 20 minute periods. Intervention 2: Control group: At first, the wound was closed three times with a normal saline serum, then with a sterile dry gel and then, depending on the size of the wound, with one or more dry sterilized gases.</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:
EMPTY

When:
EMPTY

To whom:
EMPTY

Conditions:
EMPTY

Where to obtain:
EMPTY

How to obtain:
EMPTY

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DOCTOR JALIL AZIMIAN</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>FACTULY OF NURSING- QAZVIN MEDICAL OF SCIENCE</address>
        <city>QAZVIN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34146388588</zip>
        <telephone>+98 28 1223 7267</telephone>
        <email>jazzimian@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>DOCTOR  JALIL AZIMIAN</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>FACTULY IF NURSING- QAZVIN MEDICAL OF NURSING</address>
        <city>QAZVIN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3414638588</zip>
        <telephone>+98 28 1223 7267</telephone>
        <email>jazzimian@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ankle  Brachial Index at Least 0.6
Patient's Personal consent  or Companion Patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Specific Vascular Injury Such as Buerger Disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the ulcer was washed three times with sterile normal saline, and then a high pressure oxygenated portion of 10 liters per minute was placed on the document for 20 minutes. At last, the wound was dressed with enough gas. This case is repeated three times a day.Document for 20 minute: Based on the study by Eric Blackman et al. (2010), a study of treatment of severe diabetic foot ulcers with topical oxygen: a prospective controlled study at the Ontario Wound Center Clinic in Canada on 28 diabetic patients who had two The intervention and control groups were divided into two groups of silver bandages at least twice a week and in the intervention group 60 minutes of oxygen daily with topical wound treatment oxygen therapy (TWO2) given for 90 days from Monday to Friday. Were treated. Therefore, treatment was performed in 60 minutes and in three alternating 20 minute periods.</i_keyword>
      <i_keyword>Control group: At first, the wound was closed three times with a normal saline serum, then with a sterile dry gel and then, depending on the size of the wound, with one or more dry sterilized gases.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FOOT ULCER AREA. Timepoint: Before and every 48 hours after the intervention for at least one week and (or until discharge. Method of measurement: The measurements are sterilized with Absalung.</prim_outcome>
      <prim_outcome>PAIN OF DIABETIC FOOT ULCER. Timepoint: Before AND POST INTERVENTION. Method of measurement: VISUAL ANALOG SCALE.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before intervention. Method of measurement: cohen perceived stress scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-01</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>QAZVIN UNIVERSITY MEDICAL OF SCIEMCE QAZVIN Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
