<?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>IRCT138903034011N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-17</date_registration>
      <primary_sponsor>Privait</primary_sponsor>
      <public_title>Effect of infrared radiation on the healing of lower extremity ulcers in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>To study the effect of infrared radiation on the healing of lower extremity ulcers in diabetic foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4200</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic foot.</hc_freetext>
      <i_freetext>Intervention 1: Infrared radiation to diabetic foot in case group: use of 250-W tungsten lamp, made by OSRAM Company in Germany, after washing up the ulcer in the routine procedure. Before repeating the dressing, the patient was treated by infra-red radiation, once a day and seven days a week. This was carried out in the following way: a thermometer was placed on the surrounding of the healthy skin to record the temperature of that point and to ensure that the temperature did not exceed 42 degrees centigrade. The distance between the infra-red source and the skin was 30 cm and the radiation time was 20 minutes. The radiation angle was chosen as vertical according to Cosinus Lamirt law in order to absorb the maximum radiation and then wet dressing was performed. Intervention 2: Routine dressing for control group:  patient’s ulcer and its peripheral tissues were immersed in a sterile tub of saline for 20 minutes and then they were dried by sterile gauze and were dressed in a sterile way after being put in a layer of wet gauze. This process was carried out twice a day, seven days a week. In case the dressing was removed because of excessive discharge or wetness, the dressing was repeated.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Sadeghi Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful faculty of medical Sciences, Azadegan</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 64 1526 6172</telephone>
        <email>sadeghi_ali2008@yahoo.com ; sadeghi_ali2008@.ajums.ac.ir</email>
        <affiliation>Dezful faculty of medical scinces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Sadeghi Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful university of medical Sciences, Azadegan</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 64 1526 6172</telephone>
        <email>sadeghi_ali2008@yahoo.com</email>
        <affiliation>Dezful faculty of medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1- diabetic foot ulcer in extremity organs; 2- diabetic foot ulcer of 1 or 2 degree; 3- having diabetes for at least 5 years. Exclusion criteria: 1- addiction; 2-smoking.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I79.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Peripheral angiopathy in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Infrared radiation to diabetic foot in case group: use of 250-W tungsten lamp, made by OSRAM Company in Germany, after washing up the ulcer in the routine procedure. Before repeating the dressing, the patient was treated by infra-red radiation, once a day and seven days a week. This was carried out in the following way: a thermometer was placed on the surrounding of the healthy skin to record the temperature of that point and to ensure that the temperature did not exceed 42 degrees centigrade. The distance between the infra-red source and the skin was 30 cm and the radiation time was 20 minutes. The radiation angle was chosen as vertical according to Cosinus Lamirt law in order to absorb the maximum radiation and then wet dressing was performed.</i_keyword>
      <i_keyword>Routine dressing for control group:  patient’s ulcer and its peripheral tissues were immersed in a sterile tub of saline for 20 minutes and then they were dried by sterile gauze and were dressed in a sterile way after being put in a layer of wet gauze. This process was carried out twice a day, seven days a week. In case the dressing was removed because of excessive discharge or wetness, the dressing was repeated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Healing of diabetic foot ulcer. Timepoint: Every week. Method of measurement: Check list to assess diabetic foot healing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Healing time. Timepoint: during the study. Method of measurement: time from the beginning of study.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Ahwaz Jundishapur University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Privait</source_name>
      <source_name>Ahwaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date></approval_date>
        <contact_name>Ahwaz university of medical sciences</contact_name>
        <contact_address>Central organazation of Ahwaz university of medical sciences, university town Ahwaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
