<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/NCT03788642</url>
  </required_header>
  <id_info>
    <org_study_id>Si475/2561</org_study_id>
    <nct_id>NCT03788642</nct_id>
  </id_info>
  <brief_title>Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer</brief_title>
  <official_title>Efficacy of Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</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>
      The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with&#xD;
      diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and&#xD;
      a half to recieve the placebo (LED).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with&#xD;
      diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by&#xD;
      medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT&#xD;
      shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to&#xD;
      see whether LLLT shoe helps with healing compare with placebo (LED shoe).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</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>
    <intervention_model_description>The randomised clinical trial with participants randomised1:1 to either&#xD;
Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily&#xD;
Laser group : Patients will wear Laser shoe 30 minutes once daily</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer Healing Rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Healing rate of control and laser group will be reported at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to ulcer healing</measure>
    <time_frame>time from date of randomisation to date of healing within the 12 month study period</time_frame>
    <description>For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized leg in the absence of a scab (eschar) with no dressing required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success - Complications</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Incidence of complications related to the LLT shoe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Control LED Shoe arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with DFU will wear LED shoe 30 minutes per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser Shoe arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with DFU will wear Laser shoe 30 minutes per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control LED shoe arm</intervention_name>
    <description>Patients with DFU will wear LED shoe 30 minutes once daily</description>
    <arm_group_label>Control LED Shoe arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Shoe arm</intervention_name>
    <description>Patients with DFU will wear Laser shoe 30 minutes once daily</description>
    <arm_group_label>Laser Shoe arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic diabetic foot ulcer&#xD;
&#xD;
          -  Ankle brachial index ≥ 0.4&#xD;
&#xD;
          -  Toe pressure brachial index ≥ 0.3&#xD;
&#xD;
          -  Transcutaneous oxygen measurement (TCOM) ≥ 40 mmHg&#xD;
&#xD;
          -  Ulcer size less than 25 cm2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infected ulcer&#xD;
&#xD;
          -  Fever&#xD;
&#xD;
          -  HbA1C &gt; 15 %&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuttawut SERMSATHANASAWADI, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vascular Surgery, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 16, 2021</last_update_submitted>
  <last_update_submitted_qc>December 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot Ulcer</keyword>
  <keyword>Low Level Laser Therapy</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/NCT03788642
org study id: Si475/2561
nct id: NCT03788642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with
      diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and
      a half to recieve the placebo (LED).
Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with
      diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by
      medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT
      shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to
      see whether LLLT shoe helps with healing compare with placebo (LED shoe).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The randomised clinical trial with participants randomised1:1 to either
Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily
Laser group : Patients will wear Laser shoe 30 minutes once daily
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Ulcer Healing Rate
time frame: 12 weeks
description: Healing rate of control and laser group will be reported at 12 weeks
measure: Time to ulcer healing
time frame: time from date of randomisation to date of healing within the 12 month study period
description: For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized leg in the absence of a scab (eschar) with no dressing required.
measure: Clinical Success - Complications
time frame: up to 12 months
description: Incidence of complications related to the LLT shoe
arm group label: Control LED Shoe arm
arm group type: Active Comparator
description: Patients with DFU will wear LED shoe 30 minutes per day
arm group label: Laser Shoe arm
arm group type: Active Comparator
description: Patients with DFU will wear Laser shoe 30 minutes per day
intervention type: Procedure
intervention name: Control LED shoe arm
description: Patients with DFU will wear LED shoe 30 minutes once daily
arm group label: Control LED Shoe arm
intervention type: Procedure
intervention name: Laser Shoe arm
description: Patients with DFU will wear Laser shoe 30 minutes once daily
arm group label: Laser Shoe arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nuttawut SERMSATHANASAWADI, MD, PhD
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer