<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/NCT04446767</url>
  </required_header>
  <id_info>
    <org_study_id>P.T REC/017/00482.</org_study_id>
    <nct_id>NCT04446767</nct_id>
  </id_info>
  <brief_title>Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer</brief_title>
  <official_title>Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Nourah Bint Abdulrahman University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in&#xD;
      Diabetic Foot Ulcer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in&#xD;
      Diabetic Foot Ulcer both sexes were included and intervention will be given for two months,&#xD;
      wound healing will be assessed by measuring the surface area and the Aerobic microflora will&#xD;
      be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at&#xD;
      the end of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">September 5, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histologic evaluation:</measure>
    <time_frame>two months</time_frame>
    <description>Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound assessment</measure>
    <time_frame>two months</time_frame>
    <description>The wound surface area (ulcer size), lenghth and width will measured using Ruler technique</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Wound Healing Disorder</condition>
  <arm_group>
    <arm_group_label>Bioptron light therapy and medical care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medical care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>polarized light</intervention_name>
    <description>bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks</description>
    <arm_group_label>Bioptron light therapy and medical care</arm_group_label>
    <other_name>bioptron light therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Care</intervention_name>
    <description>Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results</description>
    <arm_group_label>medical care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from&#xD;
             0.5 to 2 cm&#xD;
&#xD;
          2. Cooperative and mentally stable patients .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hepatic patients .&#xD;
&#xD;
          2. Uncontrolled hypertension .&#xD;
&#xD;
          3. Uncontrolled diabetic patients with HbA1c&gt;8.5% .&#xD;
&#xD;
          4. Neurological disorders .&#xD;
&#xD;
          5. Musculoskeletal disorders that interfere with program .&#xD;
&#xD;
          6. Previous history or any sign of DVT .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr Alaini</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 28, 2021</last_update_submitted>
  <last_update_submitted_qc>February 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mona Mohamed Taha</investigator_full_name>
    <investigator_title>ASSISTANT PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>foot ulcer</keyword>
  <keyword>polarized light</keyword>
  <keyword>;wound healing</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446767
org study id: P.T REC/017/00482.
nct id: NCT04446767
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in
      Diabetic Foot Ulcer
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in
      Diabetic Foot Ulcer both sexes were included and intervention will be given for two months,
      wound healing will be assessed by measuring the surface area and the Aerobic microflora will
      be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at
      the end of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Histologic evaluation:
time frame: two months
description: Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment
measure: Wound assessment
time frame: two months
description: The wound surface area (ulcer size), lenghth and width will measured using Ruler technique
arm group label: Bioptron light therapy and medical care
arm group type: Experimental
description: bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
arm group label: medical care
arm group type: Active Comparator
description: Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
intervention type: Radiation
intervention name: polarized light
description: bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks
arm group label: Bioptron light therapy and medical care
other name: bioptron light therapy
intervention type: Other
intervention name: Medical Care
description: Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
arm group label: medical care
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mona Mohamed Taha
investigator title: ASSISTANT PROFESSOR
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No