<?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>IRCT20190617043910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-27</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Foot Reflexology in Patients with Type II Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of Foot Reflexology in Patients with Type II Diabetes Undergoing Hemodialysis on Blood Sugar and HbA1C Level</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40286</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this research, simple randomization method was used to determine the control and intervention groups. In this way, 70 sheets were put inside a box, 35 of which were written I as intervention and the other 35 were written C as control. The box was then given to the patients to select one patient from each box with their eyes closed, Blinding description: In this one-blind study, the data analyzer does not know which control group and which intervention. But participants in the research, the researcher, the interventionist, and those involved in the preparation of the proposal are fully aware of the control and intervention groups. Also, the Committee on Safety and Data Monitoring has no role in the present trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: 70 participants were randomly divided into intervention and control groups. Intervention group: 35 patients with diabetes undergoing hemodialysis, undergoing foot reflexology for 10 minutes per foot for 3 months and 3 times per week at bedtime, in supine position, with pillow The head and one of the knees were placed in a gentle, normal environment at 20 to 24 ° C. Before the intervention, warm water was used to increase foot freshness. The towels were then dried with a towel and the odor-softening lotion was applied before the start of the reflection massage to relax the legs. Evaluation of blood glucose in two stages: 1- Before the intervention, 2- After the intervention with glucometer for three months and evaluation of glycosylated hemoglobin in two stages: 1- Before the intervention and 2- Three months after the intervention accepted. Intervention 2: Control group: 35 patients with diabetes were treated with hemodialysis for which no intervention or reflexology was performed, but routine blood glucose control treatments such as exercise, diet and medication regimens were continued as usual and blood glucose testing was continued. Glycated hemoglobin was used as the intervention group.</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:
Unnamed participants' data includes demographic information, the primary and secondary outcome of sharing.

When:
Start access after publishing the article for 6 months

To whom:
Participants in the research project

Conditions:
If the participants tend to be aware of the results of the study

Where to obtain:
Corresponding Author

How to obtain:
he applicant can access the results two weeks after the request, with written request and contact with the Corresponding author after complying with the hierarchy.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sima zahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sardasht, basij square</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>s_zahedi20@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sima zahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sardasht, basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>s_zahedi20@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having written and informed consent.
No diabetic foot ulcer or infection in massage areas
At least 3 years from the start of diagnosis of diabetes.
Have a minimum age of 30 and a maximum of 70
At least 3 years after the diagnosis of Renal failure
Lack of skin diseases such as impetigo and ...</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Type 1 diabetes
History of participation in complementary therapies such as massage, reflexology and ... up to six months ago
Having coagulation disorders such as thrombocytopenia, warfarin poisoning and ...
Unwillingness to continue cooperation
mortality or Immigration</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IV</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocrine, nutritional and metabolic diseases</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>70 participants were randomly divided into intervention and control groups. Intervention group: 35 patients with diabetes undergoing hemodialysis, undergoing foot reflexology for 10 minutes per foot for 3 months and 3 times per week at bedtime, in supine position, with pillow The head and one of the knees were placed in a gentle, normal environment at 20 to 24 ° C. Before the intervention, warm water was used to increase foot freshness. The towels were then dried with a towel and the odor-softening lotion was applied before the start of the reflection massage to relax the legs. Evaluation of blood glucose in two stages: 1- Before the intervention, 2- After the intervention with glucometer for three months and evaluation of glycosylated hemoglobin in two stages: 1- Before the intervention and 2- Three months after the intervention accepted.</i_keyword>
      <i_keyword>Control group: 35 patients with diabetes were treated with hemodialysis for which no intervention or reflexology was performed, but routine blood glucose control treatments such as exercise, diet and medication regimens were continued as usual and blood glucose testing was continued. Glycated hemoglobin was used as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of blood sugar. Timepoint: Measure of blood sugar levels before and after each intervention session, three times a week for three months. Method of measurement: Glucometer.</prim_outcome>
      <prim_outcome>Glycated hemoglobin. Timepoint: Before  and  after the intervention. Method of measurement: blood sample with Elisa kit.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-21</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>sardasht- basij square arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
