<?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>IRCT2014110819854N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of electrical stimulation on diabetic foot ulcer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cathodal direct current on the skin temperature and healing in ischemic diabetic foot ulcer, one-blind controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17644</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Diabet.</hc_freetext>
      <i_freetext>Intervention 1: In the electrical stimulation group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. The polarity of the active electrode was negative (cathode) during the treatment period. Cathodal direct current with sensory threshold intensity applied to the wound site for 1 h/day, 3 days/week and for 12 sessions. Intervention 2: In placebo group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. In the placebo group, the treatment procedure was the same as that described for the electrical stimulation group, but the current intensity was zero.</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>Mohammadreza Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 3824</telephone>
        <email>Mohammadreza.asadi@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Giti Torkaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical Therapy Department, Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 4509</telephone>
        <email>Torkamg@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main inclusion criteria: Patients with ischemic diabetic foot ulcer; Wagner classification DFU 2; both sex; mild to moderate diabetic neuropathy; 0.7&lt; ankle-brachial index&lt;0.9; HbA1c &lt; 8.2.&#13;
The main exclusion criteria: Fracture in a lower limb; severe infection; malignancy; kidney failure; skin diseases; osteomyelitis; angioplasty.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10, E11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</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>In the electrical stimulation group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. The polarity of the active electrode was negative (cathode) during the treatment period. Cathodal direct current with sensory threshold intensity applied to the wound site for 1 h/day, 3 days/week and for 12 sessions.</i_keyword>
      <i_keyword>In placebo group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. In the placebo group, the treatment procedure was the same as that described for the electrical stimulation group, but the current intensity was zero.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Skin temperature. Timepoint: Befor and after intervention, 6 and 12 days following onset of intervention. Method of measurement: Centigrade by thermometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound surface area. Timepoint: One, 6 and 12 following onset of intervention. Method of measurement: Square centimeter by standard ruler.</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>Vice chancellor for research, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-06</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
