<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01681160</url>
  </required_header>
  <id_info>
    <org_study_id>86/116</org_study_id>
    <nct_id>NCT01681160</nct_id>
  </id_info>
  <brief_title>Study of Maggot Therapy in Diabetic Foot Ulcers</brief_title>
  <acronym>MDT</acronym>
  <official_title>Maggot Therapy in Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kerman Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kerman Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was a Kind of clinical trial with equal randomization, that have been done from&#xD;
      January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128&#xD;
      diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is&#xD;
      one of the more important aims for health professional specially for nurses.One of this new&#xD;
      treatment is maggot therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">December 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>DIABETIC FOOT ULCERS</condition>
  <arm_group>
    <arm_group_label>MAGGOT THERAPY &amp; conventional therapy T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>procedure:maggot therapy</intervention_name>
    <description>each times in maggot therapy continued for three days.wound assessment was done before and after any intervention</description>
    <arm_group_label>MAGGOT THERAPY &amp; conventional therapy T</arm_group_label>
    <other_name>larval therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional therapy</intervention_name>
    <description>patients receive ordinary treatment for diabetic foot</description>
    <arm_group_label>MAGGOT THERAPY &amp; conventional therapy T</arm_group_label>
    <other_name>mechanical debridement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a chronic illness more than 7 weeks.&#xD;
&#xD;
          -  The age of the patients between 40- 90 years old.&#xD;
&#xD;
          -  Not having capillary disease (Blockage of artery, Rinold).&#xD;
&#xD;
          -  Not user of anticoagulants and corticosteroids drugs.&#xD;
&#xD;
          -  Patients without history of allergy to drugs and foods.&#xD;
&#xD;
          -  Having diabetic type 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who refer to critical clinical care unit&#xD;
&#xD;
          -  patients who have amputation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kerman Medical University</investigator_affiliation>
    <investigator_full_name>Forough Pouryazdanpanah Kermani</investigator_full_name>
    <investigator_title>university instructor</investigator_title>
  </responsible_party>
  <keyword>MAGGOT THERAPY</keyword>
  <keyword>DIABETIC FOOT</keyword>
  <keyword>NURSING CARE</keyword>
  <keyword>DRESSING</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681160
org study id: 86/116
nct id: NCT01681160
lead sponsor: 
has dmc: Yes
This study was a Kind of clinical trial with equal randomization, that have been done from
      January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128
      diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is
      one of the more important aims for health professional specially for nurses.One of this new
      treatment is maggot therapy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days
time frame: 2 years
arm group label: MAGGOT THERAPY & conventional therapy T
arm group type: Experimental
description: Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group
intervention type: Other
intervention name: procedure:maggot therapy
description: each times in maggot therapy continued for three days.wound assessment was done before and after any intervention
arm group label: MAGGOT THERAPY & conventional therapy T
other name: larval therapy
intervention type: Other
intervention name: conventional therapy
description: patients receive ordinary treatment for diabetic foot
arm group label: MAGGOT THERAPY & conventional therapy T
other name: mechanical debridement
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kerman Medical University
investigator full name: Forough Pouryazdanpanah Kermani
investigator title: university instructor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer