<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/NCT03255655</url>
  </required_header>
  <id_info>
    <org_study_id>GTS - ITU UA Plantar Fascia 01</org_study_id>
    <nct_id>NCT03255655</nct_id>
  </id_info>
  <brief_title>Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction</brief_title>
  <acronym>ITU</acronym>
  <official_title>Intense Therapeutic Ultrasound for Chronic Plantar Fascia Musculoskeletal Pain Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guided Therapy Systems</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guided Therapy Systems</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>
      Double-blinded feasibility study for the treatment of pain related to chronic plantar&#xD;
      fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2&#xD;
      treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with&#xD;
      Standard of Care treatments as prescribed by the Principal Investigator. Patients were&#xD;
      followed for up to 6 months after the first treatment receiving a physical exam at each&#xD;
      follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported&#xD;
      Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up&#xD;
      at 26 weeks after the first treatment.&#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;
&#xD;
      ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below&#xD;
      facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to&#xD;
      market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide&#xD;
      have been treated using this technology. Clinical studies have shown that 85% of patients&#xD;
      receiving this treatment on facial skin tissue showed an improvement in facial lifting with&#xD;
      no significant pain, erythema, inflammation or scarring by creating the same coagulative&#xD;
      changes to the connective tissue under the skin. Histologically, it has been shown that ITU&#xD;
      induces the production of dermal collagen with thickening of the dermis and straightening of&#xD;
      the elastic fibers in the reticular dermis.&#xD;
&#xD;
      On-going research in laboratory studies has shown that ITU can improve healing of damaged&#xD;
      Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor&#xD;
      markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor&#xD;
      necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta&#xD;
      1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated&#xD;
      with ITU compared to injured, untreated rabbit tendons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2014</start_date>
  <completion_date type="Actual">March 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</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>Adult Patients (age 18 - 85) of either gender diagnosed with chronic plantar fasciitis pain (&gt;90 days) where Standard of Care treatments had failed to reduce pain.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator was blinded to the treated vs. control/sham treated patient identity and to the treated foot.&#xD;
Researchers were blinded to the Investigators physical exam finding and patient outcome measure reports</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average Percentage of Change as Reported Using Foot Function Index Pain Subscale</measure>
    <time_frame>12 weeks after 1st Treatment</time_frame>
    <description>Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging</measure>
    <time_frame>12 Weeks after the first Treatment</time_frame>
    <description>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Chronic Plantar Fasciitis</condition>
  <arm_group>
    <arm_group_label>ITU Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham ITU Treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intense Therapeutic Ultrasound Treatment - ITU</intervention_name>
    <arm_group_label>ITU Treatment</arm_group_label>
    <arm_group_label>Sham ITU Treatment</arm_group_label>
    <other_name>Guided Therapy Systems, Ardent Sound, GTS, ITU</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;
               -  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&#xD;
             Investigational New Drug clinical trial, or who have participated in a clinical study&#xD;
             involving the 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&#xD;
                  including conservative treatment);&#xD;
&#xD;
               -  At the Principal Investigator's discretion, any patient that should be excluded&#xD;
                  based 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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Latt, Md, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Univesity of Arizona; Orthopaedic Surgery and Biomedical Engineering</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <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>DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.</citation>
    <PMID>12851352</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>October 20, 2017</results_first_submitted>
  <results_first_submitted_qc>November 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 13, 2017</results_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Plantar Fasciitis</keyword>
  <keyword>Plantar Fascia Pain</keyword>
  <keyword>Intense Therapeutic Ultrasound (ITU)</keyword>
  <keyword>Guided Therapy Systems (GTS)</keyword>
  <keyword>Ardent Sound, Inc.</keyword>
  <keyword>Actisound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <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>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 5, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03255655/Prot_000.pdf</document_url>
    </provided_document>
    <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 23, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03255655/ICF_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 23, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03255655/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients 18 - 85 years previously diagnosed with unilateral Chronic Plantar Fasciitis (&gt;90 days), where Standard of Care therapies had failed to reduce pain.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
        </group>
        <group group_id="P2">
          <title>Sham ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" 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="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
        </group>
        <group group_id="B2">
          <title>Sham ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</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="29"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="29"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="29"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="35" upper_limit="83"/>
                    <measurement group_id="B2" value="47" lower_limit="34" upper_limit="83"/>
                    <measurement group_id="B3" value="51" lower_limit="34" upper_limit="83"/>
                  </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="29"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Percentage of Change as Reported Using Foot Function Index Pain Subscale</title>
        <description>Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.</description>
        <time_frame>12 weeks after 1st Treatment</time_frame>
        <population>Total population of respondents at 12 weeks.</population>
        <group_list>
          <group group_id="O1">
            <title>ITU Treatment for Chronic Plantar Fasciitis</title>
            <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
          </group>
          <group group_id="O2">
            <title>Sham ITU Treatment for Chronic Plantar Fasciitis</title>
            <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percentage of Change as Reported Using Foot Function Index Pain Subscale</title>
          <description>Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.</description>
          <population>Total population of respondents at 12 weeks.</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="22"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54" lower_limit="-100" upper_limit="100"/>
                    <measurement group_id="O2" value="-25" lower_limit="-100" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging</title>
        <description>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).</description>
        <time_frame>12 Weeks after the first Treatment</time_frame>
        <population>Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.</population>
        <group_list>
          <group group_id="O1">
            <title>ITU Treatment for Chronic Plantar Fasciitis</title>
            <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
          </group>
          <group group_id="O2">
            <title>Sham ITU Treatment for Chronic Plantar Fasciitis</title>
            <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging</title>
          <description>Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).</description>
          <population>Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.</population>
          <units>percentage of Hypoechoic Lesion Change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-81" spread="8"/>
                    <measurement group_id="O2" value="26" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years, 9 months</time_frame>
      <desc>Any Patient Self-Reported Adverse Event occurring during the treatment or during the Follow-up Period.</desc>
      <group_list>
        <group group_id="E1">
          <title>ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
        </group>
        <group group_id="E2">
          <title>Sham ITU Treatment for Chronic Plantar Fasciitis</title>
          <description>Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.&#xD;
Intense Therapeutic Ultrasound Treatment - ITU</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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>
    <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/NCT03255655
org study id: GTS - ITU UA Plantar Fascia 01
nct id: NCT03255655
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Double-blinded feasibility study for the treatment of pain related to chronic plantar
      fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2
      treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with
      Standard of Care treatments as prescribed by the Principal Investigator. Patients were
      followed for up to 6 months after the first treatment receiving a physical exam at each
      follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported
      Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up
      at 26 weeks after the first treatment.
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.

      ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below
      facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to
      market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide
      have been treated using this technology. Clinical studies have shown that 85% of patients
      receiving this treatment on facial skin tissue showed an improvement in facial lifting with
      no significant pain, erythema, inflammation or scarring by creating the same coagulative
      changes to the connective tissue under the skin. Histologically, it has been shown that ITU
      induces the production of dermal collagen with thickening of the dermis and straightening of
      the elastic fibers in the reticular dermis.

      On-going research in laboratory studies has shown that ITU can improve healing of damaged
      Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor
      markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor
      necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta
      1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated
      with ITU compared to injured, untreated rabbit tendons.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Adult Patients (age 18 - 85) of either gender diagnosed with chronic plantar fasciitis pain (>90 days) where Standard of Care treatments had failed to reduce pain.
primary purpose: Treatment
masking: Single (Investigator)
masking description: Investigator was blinded to the treated vs. control/sham treated patient identity and to the treated foot.
Researchers were blinded to the Investigators physical exam finding and patient outcome measure reports
measure: Average Percentage of Change as Reported Using Foot Function Index Pain Subscale
time frame: 12 weeks after 1st Treatment
description: Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.
measure: Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging
time frame: 12 Weeks after the first Treatment
description: Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).
arm group label: ITU Treatment
arm group type: Experimental
description: Intense Therapeutic Ultrasound (ITU) treatment applied along the length and width of the Plantar Fascia: 350 - 5 Joule pulses were applied twice, two weeks apart.
arm group label: Sham ITU Treatment
arm group type: Placebo Comparator
description: Sham / Placebo Intense Therapeutic Ultrasound treatment (ITU) applied along the length and width of the Plantar Fascia: 350 - 0 Joule pulses were applied twice, two weeks apart.
intervention type: Device
intervention name: Intense Therapeutic Ultrasound Treatment - ITU
arm group label: ITU Treatment
arm group label: Sham ITU Treatment
other name: Guided Therapy Systems, Ardent Sound, GTS, ITU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dan Latt, Md, Ph.D.
role: Principal Investigator
affiliation: University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery
facility: 
country: United States
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: DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
PMID: 12851352
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
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: 
point of contact: 