<?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>IRCT20160711028878N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-01</date_registration>
      <primary_sponsor>Isfahan Research Department of Medical Sciences</primary_sponsor>
      <public_title>Effect of a mixture of doxycycline and venlafaxine on the healing of diabetic foot ulcers</public_title>
      <acronym></acronym>
      <scientific_title>Therapeutic potential of loaded doxycycline and Venlafaxine on nanofiber scaffolds for wound healing in diabetic foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37678</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was a simple randomization study where 1 to 40 were written on a sheet and placed in a box in a manner that was unclear. One sheet was taken for each patient. Even numbers were assigned as the treatment group and odd numbers as the control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Treatment of diabetic foot ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Nanofibers containing doxycycline and venlafaxine were prepared from Nano Novin Polymer Factory (NATO MAND), then FTIR test was used to determine drug quantity and release rate.  Their mechanical strength was then tested with a Tensile device.  The morphology of the samples was analyzed by electron microscopy (TEM).  The patients' foot ulcers were washed with serum and the nano-fiber scaffolds were placed on their wounds every other day, with treatment continued for one week to 20 days.  Finally, the skin permeability of the drugs to nanofibers was tested on the hairless abdominal skin of the rat. The results were measured for a total duration of 12 weeks with a spectrophotometer. Intervention 2: Control group: This group had their normal treatment and scaffold dressing was not used to them.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is a need for further coordination with the center for dissemination</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rokhsareh Meamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences-University St.-Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶-۷۳۴۶۱</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>meamar@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rokhsareh Meamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences-University Street.-Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶-۷۳۴۶۱</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>meamar@pharm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 45 and 65 years
Having diabetic foot ulcers that have not recovered despite a treatment during the past month (2-7 cm)
Having pain at rest and walking
Signature written consent</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
septicemia
Other systemic kidney diseases, such as cancer, autoimmune diseases, blood diseases, liver disease and ...
Hospitalization due to severe illness in the past two months
Severe malnutrition
The presence of ulcers at the feet of patients, except for diabetes, for example syphilis, tuberculosis, or fungal foot
Any allergy to the compounds used in the production of scaffolding
Having osteomyelitis in the diabetic foot
History of previous wound in the same place</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 circulatory complications</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Nanofibers containing doxycycline and venlafaxine were prepared from Nano Novin Polymer Factory (NATO MAND), then FTIR test was used to determine drug quantity and release rate.  Their mechanical strength was then tested with a Tensile device.  The morphology of the samples was analyzed by electron microscopy (TEM).  The patients' foot ulcers were washed with serum and the nano-fiber scaffolds were placed on their wounds every other day, with treatment continued for one week to 20 days.  Finally, the skin permeability of the drugs to nanofibers was tested on the hairless abdominal skin of the rat. The results were measured for a total duration of 12 weeks with a spectrophotometer.</i_keyword>
      <i_keyword>Control group: This group had their normal treatment and scaffold dressing was not used to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Size of the Ulcer. Timepoint: Before starting the study, 2 weeks and in months of 1,2,12,18 after using drugs. Method of measurement: biopsy.</prim_outcome>
      <prim_outcome>Distance walked without pain. Timepoint: Before starting the study, 2 weeks and in months of 1,2,12,18 after using drugs. Method of measurement: Meter.</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>Isfahan Research Department of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-27</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, University Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
