<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/NCT03254602</url>
  </required_header>
  <id_info>
    <org_study_id>20160753</org_study_id>
    <nct_id>NCT03254602</nct_id>
  </id_info>
  <brief_title>Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis</brief_title>
  <acronym>ITU</acronym>
  <official_title>Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Foot and Ankle Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guided Therapy Systems</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Foot and Ankle Foundation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of&#xD;
      Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue&#xD;
      pain reduction began in August 2016 and was completed in April 2017. The clinical setting:&#xD;
      University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal&#xD;
      study for chronic plantar fasciitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which&#xD;
      sound waves are concentrated and focused into selected musculoskeletal tissue, to produce&#xD;
      selective thermal coagulative changes over a small controlled area while leaving the&#xD;
      surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue&#xD;
      response cascade and promote collagen generation in the targeted anatomy resulting in pain&#xD;
      reduction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2016</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction</measure>
    <time_frame>At 12 weeks after the first treatment</time_frame>
    <description>Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound Changes</measure>
    <time_frame>At 12 Weeks after the first treatment</time_frame>
    <description>Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline</measure>
    <time_frame>At 12 Weeks after the first treatment</time_frame>
    <description>Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Plantar Fasciitis, Chronic</condition>
  <arm_group>
    <arm_group_label>Intense Therapeutic Ultrasound Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Therapeutic Ultrasound Treatment</intervention_name>
    <arm_group_label>Intense Therapeutic Ultrasound Treatment</arm_group_label>
    <other_name>Guided Therapy Systems, Ardent Sound, GTS, ITU</other_name>
    <other_name>Actisound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Pain (&gt;90 days) from previously diagnosed Plantar Fasciitis, where &quot;Standard&#xD;
             of Care&quot; regimens failed to relief pain in the affected anatomy.&#xD;
&#xD;
          -  No History of surgery to the affected anatomy.&#xD;
&#xD;
          -  No alternative treatment procedures within the last 90 days.&#xD;
&#xD;
          -  Age: 18 - 85, depending on the study.&#xD;
&#xD;
          -  Unilateral Pain&#xD;
&#xD;
          -  Willingness to complete treatment and post treatment regimen as described.&#xD;
&#xD;
          -  Patients who have provided written and verbal informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently enrolled in any other non-conservative, device, or Investigational&#xD;
             New Drug clinical trial, or who have participated in a clinical study involving the&#xD;
             Plantar Fascia, thirty days prior to study initiation;&#xD;
&#xD;
          -  Patients who have participated in any other clinical study involving an&#xD;
             investigational product 30 days prior to enrollment that, in the opinion of the&#xD;
             Principal Investigator, could affect the outcome of this study;&#xD;
&#xD;
          -  Patients who have received previous treatment in the symptomatic limb (not including&#xD;
             conservative treatment);&#xD;
&#xD;
          -  At the Principal Investigator's discretion, any patient that should be excluded based&#xD;
             on their current condition or medical history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bob Baravarian, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Foot and Ankle Foundation</affiliation>
  </overall_official>
  <reference>
    <citation>White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.</citation>
    <PMID>17224484</PMID>
  </reference>
  <reference>
    <citation>Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.</citation>
    <PMID>20115948</PMID>
  </reference>
  <reference>
    <citation>Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.</citation>
    <PMID>17372061</PMID>
  </reference>
  <reference>
    <citation>Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.</citation>
    <PMID>18429926</PMID>
  </reference>
  <reference>
    <citation>Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.</citation>
    <PMID>12696985</PMID>
  </reference>
  <reference>
    <citation>Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.</citation>
    <PMID>16801514</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>August 21, 2017</results_first_submitted>
  <results_first_submitted_qc>October 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03254602/ICF_000.pdf</document_url>
    </provided_document>
    <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>April 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03254602/Prot_001.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>May 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03254602/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Patient Age at time of first treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="31" upper_limit="73"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients with Chronic Plantar Fasciitis where Standard of Care Therapy failed to Reduce Pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction</title>
        <description>Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.</description>
        <time_frame>At 12 weeks after the first treatment</time_frame>
        <population>Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.</population>
        <group_list>
          <group group_id="O1">
            <title>Intense Therapeutic Ultrasound Treatment</title>
            <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction</title>
          <description>Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.</description>
          <population>Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.</population>
          <units>Percent of Patients meeting criteria</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ultrasound Changes</title>
        <description>Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments</description>
        <time_frame>At 12 Weeks after the first treatment</time_frame>
        <population>Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions</population>
        <group_list>
          <group group_id="O1">
            <title>Intense Therapeutic Ultrasound Treatment</title>
            <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Ultrasound Changes</title>
          <description>Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments</description>
          <population>Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions</population>
          <units>percentage of Lesion Size Reduction</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline</title>
        <description>Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)</description>
        <time_frame>At 12 Weeks after the first treatment</time_frame>
        <population>Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago</population>
        <group_list>
          <group group_id="O1">
            <title>Intense Therapeutic Ultrasound Treatment</title>
            <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline</title>
          <description>Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)</description>
          <population>Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago</population>
          <units>percentage of Change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean % PF Pain Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54" lower_limit="-100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mean % Change in PF Hypoechoic Lesion Volume</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56" lower_limit="-100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Any patient reported event occurring after the first treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intense Therapeutic Ultrasound Treatment</title>
          <description>Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment</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="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </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="29"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Bias was mitigated as much as possible within the protocol by way of the blinding throughout the layers of patients and personnel involved in the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rich Amodei, RDMS</name_or_title>
      <organization>Guided Therapy Systems</organization>
      <phone>480-649-8587</phone>
      <email>r.amodei@guidedtherapy.com</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/NCT03254602
org study id: 20160753
nct id: NCT03254602
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of
      Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue
      pain reduction began in August 2016 and was completed in April 2017. The clinical setting:
      University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal
      study for chronic plantar fasciitis.
Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which
      sound waves are concentrated and focused into selected musculoskeletal tissue, to produce
      selective thermal coagulative changes over a small controlled area while leaving the
      surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue
      response cascade and promote collagen generation in the targeted anatomy resulting in pain
      reduction.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction
time frame: At 12 weeks after the first treatment
description: Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.
measure: Ultrasound Changes
time frame: At 12 Weeks after the first treatment
description: Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments
measure: Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
time frame: At 12 Weeks after the first treatment
description: Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)
arm group label: Intense Therapeutic Ultrasound Treatment
arm group type: Experimental
description: Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart.
intervention type: Device
intervention name: Intense Therapeutic Ultrasound Treatment
arm group label: Intense Therapeutic Ultrasound Treatment
other name: Guided Therapy Systems, Ardent Sound, GTS, ITU
other name: Actisound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bob Baravarian, DPM
role: Principal Investigator
affiliation: University Foot and Ankle Foundation
citation: White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.
PMID: 17224484
citation: Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.
PMID: 20115948
citation: Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.
PMID: 17372061
citation: Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.
PMID: 18429926
citation: Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
PMID: 12696985
citation: Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.
PMID: 16801514
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Bias was mitigated as much as possible within the protocol by way of the blinding throughout the layers of patients and personnel involved in the study.
point of contact: 