<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/NCT03821675</url>
  </required_header>
  <id_info>
    <org_study_id>H-44704</org_study_id>
    <nct_id>NCT03821675</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation to Accelerate Wound Healing</brief_title>
  <official_title>Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People With Diabetic Foot Ulcers - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Avazzia, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and&#xD;
      Endovascular Therapy, is being proposed to test the efficacy of a novel electrical&#xD;
      stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound&#xD;
      healing, relieve pain and improve mobility in patients with diabetic foot ulcers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electrical stimulation may offer a unique treatment option to heal complicated and&#xD;
      recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of&#xD;
      ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular&#xD;
      immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound&#xD;
      healing.&#xD;
&#xD;
      Electrical stimulation could have positive effect on not only increasing skin perfusion in&#xD;
      patients with diabetes but also could improve mobility and balance via enhancing plantar&#xD;
      sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be&#xD;
      beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may&#xD;
      assist to improve mobility and reduce the likelihood of recurrence of ulcers.&#xD;
&#xD;
      This study is proposed to examine the effectiveness of an innovative portable electrical&#xD;
      stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU&#xD;
      patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on&#xD;
      increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator&#xD;
      for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion,&#xD;
      reduce pain, and improve balance and mobility in DFU patients (long term benefit)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">October 8, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Devices may be active or sham.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Skin Perfusion in Response to Electrical Stimulation Therapy</measure>
    <time_frame>Change at 4 weeks from baseline.</time_frame>
    <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Wound Size in Response to Electrical Stimulation Therapy</measure>
    <time_frame>Change at 4 weeks from baseline</time_frame>
    <description>Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Plantar Sensation in Response to Electrical Stimulation</measure>
    <time_frame>Change at 4 weeks from baseline.</time_frame>
    <description>change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation</measure>
    <time_frame>Change at 60 minutes from baseline.</time_frame>
    <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tissue Oxygen Saturation in Response to Electrical Stimulation</measure>
    <time_frame>Change at 4 weeks from baseline.</time_frame>
    <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in Skin Perfusion in Response to Electrical Stimulation</measure>
    <time_frame>an average of 60 minutes from baseline</time_frame>
    <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Peripheral Neuropathy</condition>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Electrical Stimulation - Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrical Stimulation - Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Stimulation - Active</intervention_name>
    <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
    <arm_group_label>Electrical Stimulation - Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Stimulation - Sham</intervention_name>
    <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
    <arm_group_label>Electrical Stimulation - Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  18-85 years old&#xD;
&#xD;
          -  Clinically confirmed diabetes (ADA criteria)&#xD;
&#xD;
          -  Clinically confirmed Peripheral Neuropathy&#xD;
&#xD;
          -  One or more active non-infected ulcers&#xD;
&#xD;
          -  Subject or responsible caregiver is willing and to maintain the required offloading&#xD;
             (as applicable the location of the ulcer) and applicable dressing changes and&#xD;
             electrical stimulation application.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a demand-type cardiac pacemaker, implanted defibrillator or other&#xD;
             implanted electronic device&#xD;
&#xD;
          -  Is pregnant&#xD;
&#xD;
          -  Is nursing or actively lactating&#xD;
&#xD;
          -  Has Renal Disease&#xD;
&#xD;
          -  Active wound infection&#xD;
&#xD;
          -  Active Charcot foot&#xD;
&#xD;
          -  Non-ambulatory (unable to walk 40 feet with or without assistive device)&#xD;
&#xD;
          -  Bilateral AK/BK amputation&#xD;
&#xD;
          -  Active drug/alcohol abuse&#xD;
&#xD;
          -  Dementia or impaired cognitive function&#xD;
&#xD;
          -  Excessive lymphedema&#xD;
&#xD;
          -  Osteomyelitis and/or gangrene&#xD;
&#xD;
          -  Unable to comply with research appointments (e.g. long travel) Wide spread malignancy&#xD;
             or systemically imumno-compromising disease&#xD;
&#xD;
          -  Subject has a history of or any intercurrent illnesses or conditions that would&#xD;
             compromise the safety of the subject according to judgement of a qualified wound&#xD;
             specialist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>October 12, 2021</results_first_submitted>
  <results_first_submitted_qc>April 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 9, 2022</results_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Bijan Najafi, PhD</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>electrical stimulation</keyword>
  <keyword>wound healing</keyword>
  <keyword>skin perfusion</keyword>
  <keyword>home based therapy</keyword>
  <keyword>diabetic foot</keyword>
  <keyword>Foot ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03821675/Prot_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03821675/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active</title>
          <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Sham</title>
          <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active</title>
          <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Sham</title>
          <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.1" spread="13.8"/>
                    <measurement group_id="B2" value="61.4" spread="11.2"/>
                    <measurement group_id="B3" value="63.2" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Skin Perfusion in Response to Electrical Stimulation Therapy</title>
        <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
        <time_frame>Change at 4 weeks from baseline.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Skin Perfusion in Response to Electrical Stimulation Therapy</title>
          <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.1" spread="19.1"/>
                    <measurement group_id="O2" value="72.2" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Wound Size in Response to Electrical Stimulation Therapy</title>
        <description>Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.</description>
        <time_frame>Change at 4 weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Wound Size in Response to Electrical Stimulation Therapy</title>
          <description>Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.</description>
          <units>cm2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="8"/>
                    <measurement group_id="O2" value="3.2" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plantar Sensation in Response to Electrical Stimulation</title>
        <description>change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.</description>
        <time_frame>Change at 4 weeks from baseline.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plantar Sensation in Response to Electrical Stimulation</title>
          <description>change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.</description>
          <units>Volts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="14"/>
                    <measurement group_id="O2" value="32.1" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation</title>
        <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.</description>
        <time_frame>Change at 60 minutes from baseline.</time_frame>
        <population>Active electrical stimulation was performed during one hour on all participants before randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects did not receive sham device for this outcome measure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation</title>
          <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.</description>
          <population>Active electrical stimulation was performed during one hour on all participants before randomization.</population>
          <units>SatO2%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tissue Oxygen Saturation in Response to Electrical Stimulation</title>
        <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)</description>
        <time_frame>Change at 4 weeks from baseline.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tissue Oxygen Saturation in Response to Electrical Stimulation</title>
          <description>Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)</description>
          <units>SatO2%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3" spread="21.5"/>
                    <measurement group_id="O2" value="73.9" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change From Baseline in Skin Perfusion in Response to Electrical Stimulation</title>
        <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
        <time_frame>an average of 60 minutes from baseline</time_frame>
        <population>Active electrical stimulation was performed during one hour on all participants before randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>Subjects will receive an active electrical stimulation device to wear for 1 hour</description>
          </group>
          <group group_id="O2">
            <title>Sham</title>
            <description>Subjects did not receive sham device for this outcome measure.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Skin Perfusion in Response to Electrical Stimulation</title>
          <description>Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.</description>
          <population>Active electrical stimulation was performed during one hour on all participants before randomization.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>an average of 4 weeks from baseline.</time_frame>
      <desc>0</desc>
      <group_list>
        <group group_id="E1">
          <title>Active</title>
          <description>intervention</description>
        </group>
        <group group_id="E2">
          <title>Sham</title>
          <description>control</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Bijan Najafi</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>17137987536</phone>
      <email>bijan.najafi@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03821675
org study id: H-44704
nct id: NCT03821675
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and
      Endovascular Therapy, is being proposed to test the efficacy of a novel electrical
      stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound
      healing, relieve pain and improve mobility in patients with diabetic foot ulcers.
Electrical stimulation may offer a unique treatment option to heal complicated and
      recalcitrant wounds, improve flap and graft survival, and even reduce the likelihood of
      ulceration. Electrical stimulation has been suggested to reduce infection, improve cellular
      immunity, increase perfusion, relieve pain, improve plantar sensation, and accelerate wound
      healing.

      Electrical stimulation could have positive effect on not only increasing skin perfusion in
      patients with diabetes but also could improve mobility and balance via enhancing plantar
      sensation as demonstrated in our recent study. Thus, plantar stimulation not only may be
      beneficial to accelerate wound healing in diabetic foot ulcer (DFU) patients but also may
      assist to improve mobility and reduce the likelihood of recurrence of ulcers.

      This study is proposed to examine the effectiveness of an innovative portable electrical
      stimulation platform (Tennant Biomodulator by AVAZZIA) to accelerate wound healing in DFU
      patients. It is hypothesized that 1) electrical stimulation will have an immediate effect on
      increasing skin perfusion (immediate benefit) and 2) daily use of the Tennant Biomodulator
      for 4 consecutive weeks is effective to speed up wound healing, increase skin perfusion,
      reduce pain, and improve balance and mobility in DFU patients (long term benefit)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
masking description: Devices may be active or sham.
measure: Change in Skin Perfusion in Response to Electrical Stimulation Therapy
time frame: Change at 4 weeks from baseline.
description: Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.
measure: Change in Wound Size in Response to Electrical Stimulation Therapy
time frame: Change at 4 weeks from baseline
description: Wound size will be assessed with a Sillouette Star 3D Camera that detects width, length, and depth of wounds that automatically gives you a cm2 area.
measure: Change in Plantar Sensation in Response to Electrical Stimulation
time frame: Change at 4 weeks from baseline.
description: change in plantar sensation will be assessed with a vibration pressure threshold device placed on the heel.
measure: Change From Baseline to 60 Minutes in Tissue Oxygen Saturation in Response to Electrical Stimulation
time frame: Change at 60 minutes from baseline.
description: Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging) at 60 minutes from baseline.
measure: Change in Tissue Oxygen Saturation in Response to Electrical Stimulation
time frame: Change at 4 weeks from baseline.
description: Plantar tissue oxygen saturation will be assessed with Near infrared Spectroscopy device (KENT Imaging)
measure: Change From Baseline in Skin Perfusion in Response to Electrical Stimulation
time frame: an average of 60 minutes from baseline
description: Lower-extremity skin perfusion will be assessed using a skin perfusion pressure device (PADIQ Sensilase). This device emerges pressure with a cuff placed around the calf muscle that has internal sensors. Then, the cuff is slowly released letting circulation to re-enter which is detected by the sensors.
arm group label: Electrical Stimulation - Active
arm group type: Active Comparator
description: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
arm group label: Electrical Stimulation - Sham
arm group type: Sham Comparator
description: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
intervention type: Device
intervention name: Electrical Stimulation - Active
description: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
arm group label: Electrical Stimulation - Active
intervention type: Device
intervention name: Electrical Stimulation - Sham
description: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
arm group label: Electrical Stimulation - Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Bijan Najafi, PhD
investigator title: Professor of Surgery
mesh term: Peripheral Nervous System Diseases
mesh term: Diabetic Foot
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 