<?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>IRCT20230910059395N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-03</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Low-level laser therapy and Transcutaneous Electrical Nerve Stimulation for Treating Diabetic  peripheral Neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Low-level laser therapy and Transcutaneous Electrical Nerve Stimulation for Treating Diabetic  peripheral Neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81513</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size )60 patients) will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention or control groups based on generated numbers.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetic neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The conventional treatment method will continue (without receiving any new intervention). Intervention 2: Intervention group: Second group: The conventional treatment method combined with low-power laser therapy, which duration of the laser therapy will be 6 weeks (12 sessions), with 2 sessions of 30-minute  per week. The laser therapy device is Icoone Laser Med Italy (2022). Intervention 3: Intervention group: Third group: Conventional treatment method combined with transcutaneous electrical nerve stimulation, the duration of treatment will be 6 weeks (12 sessions), with 2 sessions of 15-minute  per week based on modulated type.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ebrahim Mohammmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital., Ershad Ave., Modarres Blvd.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57157-89397</zip>
        <telephone>+98 44 3345 7286</telephone>
        <email>mohammadi.e@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ebrahim Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital., Ershad Ave., Modarres Blvd.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57157-89397</zip>
        <telephone>+98 44 3345 7286</telephone>
        <email>mohammadi.e@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 or type 1 diabetes with at least 5 years of diabetes history
Having diabetic neuropathy of the lower extremities with a confirmed diagnosis by a neurologist
Patients treated with conventional pharmacotherapy methods (including gabapentin, pregabalin, duloxetine, TCAs, and other drugs) for at least three months</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other lower limb problems and diseases
History of any lower limb amputation
Lower limb trauma
Stroke history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E13.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified diabetes mellitus with neurological complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The conventional treatment method will continue (without receiving any new intervention)</i_keyword>
      <i_keyword>Intervention group: Second group: The conventional treatment method combined with low-power laser therapy, which duration of the laser therapy will be 6 weeks (12 sessions), with 2 sessions of 30-minute  per week. The laser therapy device is Icoone Laser Med Italy (2022).</i_keyword>
      <i_keyword>Intervention group: Third group: Conventional treatment method combined with transcutaneous electrical nerve stimulation, the duration of treatment will be 6 weeks (12 sessions), with 2 sessions of 15-minute  per week based on modulated type.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical symptoms (pain and heat, pressure sensation (monofilament), position, superficial and deep touch, paraesthesia, anesthesia, lower limb pulse). Timepoint: Before and 6 weeks after the intervention. Method of measurement: Clinical examination based on expert opinion.</prim_outcome>
      <prim_outcome>Motor nerve conduction velocity. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Nerve and leg muscle stripe test.</prim_outcome>
      <prim_outcome>Neuropathic motor potential. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Nerve and leg muscle stripe test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neuropathic sensory potential amplitude. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Nerve and leg muscle strip test.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-11</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini hospital., Modarres Blvd., Ershad Ave. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
