<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/NCT02222376</url>
  </required_header>
  <id_info>
    <org_study_id>DIA-1031-13/14-1</org_study_id>
    <nct_id>NCT02222376</nct_id>
  </id_info>
  <brief_title>Effect of Topic Pirfenidone in Diabetic Ulcers</brief_title>
  <acronym>PirDFI</acronym>
  <official_title>Effect of Treatment of Diabetic Foot Ulcers With Topic 8% 1-phenyl-5-methyl-2-[1h]-Pyridone (Pirfenidone) Combined With Modified Disulfur Diallyl Oxide (Odd-m) in Gel.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of&#xD;
      various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and&#xD;
      vascular endothelial growth factor, among others) that possesses anti-inflammatory and&#xD;
      anti-fibrinolytic properties.&#xD;
&#xD;
      The aim of this study is to compare the effect of topic treatment with pirfenidone compared&#xD;
      to conventional treatment in chronic diabetic foot ulcers.&#xD;
&#xD;
      The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers&#xD;
      (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional&#xD;
      treatment. This is a randomized, controlled and crossover study. Patients will be randomly&#xD;
      assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this&#xD;
      period they will change groups. Each week ulcers will be for size, depth, length and evidence&#xD;
      of infection. The ulcers will have proper debridement in the conventional treatment group and&#xD;
      debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be&#xD;
      instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in&#xD;
      addition to cleansing they will be instructed to apply the gel twice a day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer size</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Healed ulcers</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse effects</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Healing time</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetic Foot Ulcers</condition>
  <arm_group>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly ulcer debridement and daily cleansing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pirfenidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pirfenidone</intervention_name>
    <description>Twice a day topical application</description>
    <arm_group_label>Pirfenidone</arm_group_label>
    <other_name>Kitoscell Q</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Debridement</intervention_name>
    <description>Weekly ulcer debridement</description>
    <arm_group_label>Conventional treatment</arm_group_label>
    <arm_group_label>Pirfenidone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women&#xD;
&#xD;
          2. Type 1 or 2 diabetes&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
          4. Wagner 1 or 2 diabetic foot ulcer&#xD;
&#xD;
          5. Diabetic ulcer for more than 8 weeks duration&#xD;
&#xD;
          6. Willing to participate in the study with signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ankle/brachial index &lt; 0.4 (critic ischemia)&#xD;
&#xD;
          2. Use topical or systemic antibiotics&#xD;
&#xD;
          3. Inability to attend to the weekly evaluations&#xD;
&#xD;
          4. Inability to do daily ulcer cleansing&#xD;
&#xD;
          5. Autoimmune diseases&#xD;
&#xD;
          6. Active pharmacologic topical or systemic ulcer treatment&#xD;
&#xD;
          7. Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy&#xD;
&#xD;
          8. Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francisco J Gomez-Perez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>February 12, 2016</last_update_submitted>
  <last_update_submitted_qc>February 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic ulcer, diabetic foot</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pirfenidone</mesh_term>
  </intervention_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/NCT02222376
org study id: DIA-1031-13/14-1
nct id: NCT02222376
lead sponsor: 
has dmc: No
Pirfenidone is a synthetic molecule, which acts as a potent modulator of the effect of
      various cytokines (TNF-α, transforming growth factor-β, platelet derived growth factor and
      vascular endothelial growth factor, among others) that possesses anti-inflammatory and
      anti-fibrinolytic properties.

      The aim of this study is to compare the effect of topic treatment with pirfenidone compared
      to conventional treatment in chronic diabetic foot ulcers.

      The hypothesis is that treatment with topic pirfenidone in chronic diabetic foot ulcers
      (Wagner 1 to 2) reduces the ulcer size and shortens the healing time compared to conventional
      treatment. This is a randomized, controlled and crossover study. Patients will be randomly
      assigned to conventional treatment or topic pirfenidone for eight weeks. At the end of this
      period they will change groups. Each week ulcers will be for size, depth, length and evidence
      of infection. The ulcers will have proper debridement in the conventional treatment group and
      debridement plus topical pirfenidone application in the pirfenidone group. Subjects will be
      instructed to do daily ulcer cleansing and for those in the topical pirfenidone group, in
      addition to cleansing they will be instructed to apply the gel twice a day.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ulcer size
time frame: 16 weeks
measure: Healed ulcers
time frame: 16 weeks
measure: Adverse effects
time frame: 16 weeks
measure: Healing time
time frame: 16 weeks
arm group label: Conventional treatment
arm group type: Active Comparator
description: Weekly ulcer debridement and daily cleansing
arm group label: Pirfenidone
arm group type: Experimental
description: Weekly ulcer debridement, daily cleansing, plus twice a day topical pirfenidone application
intervention type: Drug
intervention name: Pirfenidone
description: Twice a day topical application
arm group label: Pirfenidone
other name: Kitoscell Q
intervention type: Procedure
intervention name: Debridement
description: Weekly ulcer debridement
arm group label: Conventional treatment
arm group label: Pirfenidone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francisco J Gomez-Perez, MD
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
mesh term: Pirfenidone