<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/NCT01708187</url>
  </required_header>
  <id_info>
    <org_study_id>OH1-12-00396</org_study_id>
    <nct_id>NCT01708187</nct_id>
  </id_info>
  <brief_title>The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model</brief_title>
  <acronym>Amniox</acronym>
  <official_title>The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthopedic Foot and Ankle Center, Ohio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthopedic Foot and Ankle Center, Ohio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all&#xD;
      flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal&#xD;
      tendon gliding is key to their function as effective plantar flexors and evertors of the&#xD;
      hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction&#xD;
      at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for&#xD;
      standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal&#xD;
      adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing&#xD;
      Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft&#xD;
      will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic&#xD;
      Membrane in conjunction with a peroneal tendon repair will decrease that amount of&#xD;
      inflammation, overall recovery time of surgically repaired peroneal tendon tears, and&#xD;
      adhesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Protocol halted due to less than anticipated recruitment.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Ankle Pain, Inflammation, Function &amp; Activity Limitation From Baseline to 12 Months</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.&#xD;
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Tendon Tears</condition>
  <arm_group>
    <arm_group_label>Clarix™1k graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm without Clarix™1k graft</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Clarix™1k graft</intervention_name>
    <description>Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.&#xD;
Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.</description>
    <arm_group_label>Clarix™1k graft</arm_group_label>
    <other_name>cryopreserved Human Amniotic Membrane (C-HAM) graft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients requiring surgical repair of the peroneal tendon&#xD;
&#xD;
          2. Patients who voluntarily consent to research participation&#xD;
&#xD;
          3. Patients over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who display a high surgical risk as determined by the investigative surgeon&#xD;
&#xD;
          2. Previous surgical repair of the peroneal tendon less than 2 years prior to surgery&#xD;
&#xD;
          3. Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's&#xD;
             opinion&#xD;
&#xD;
          4. Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B&#xD;
&#xD;
          5. Patients who are pregnant or breast feeding.&#xD;
&#xD;
          6. Patients who have had a clinically diagnosed autoimmune disease&#xD;
&#xD;
          7. Patients who are unwilling to restrict pre and postoperative anti-inflammatories with&#xD;
             the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative&#xD;
             immobilization period&#xD;
&#xD;
          8. Patients with an active infection&#xD;
&#xD;
          9. Patients who have a medical history that would likely make the patient an unreliable&#xD;
             research participant&#xD;
&#xD;
         10. Patients requiring surgical repair of the peroneus longus tendon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory C Berlet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic Foot and Ankle Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopedic Foot and Ankle Center</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>April 13, 2016</results_first_submitted>
  <results_first_submitted_qc>April 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 19, 2016</results_first_posted>
  <last_update_submitted>September 29, 2016</last_update_submitted>
  <last_update_submitted_qc>September 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orthopedic Foot and Ankle Center, Ohio</investigator_affiliation>
    <investigator_full_name>Greg Berlet</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Peroneal tendon</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Clarix™1k Graft</title>
          <description>Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.</description>
        </group>
        <group group_id="P2">
          <title>Control Arm Without Clarix™1k Graft</title>
          <description>Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clarix™1k Graft</title>
          <description>Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.</description>
        </group>
        <group group_id="B2">
          <title>Control Arm Without Clarix™1k Graft</title>
          <description>Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.</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="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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 Ankle Pain, Inflammation, Function &amp; Activity Limitation From Baseline to 12 Months</title>
        <description>Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.&#xD;
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score</description>
        <time_frame>Baseline,12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clarix™1k Graft</title>
            <description>Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm Without Clarix™1k Graft</title>
            <description>Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ankle Pain, Inflammation, Function &amp; Activity Limitation From Baseline to 12 Months</title>
          <description>Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.&#xD;
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score</description>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS pain at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS pain at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in VAS pain from Baseline to 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FFI at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FFI at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in FFI from Baseline to 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-57.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AOFAS at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AOFAS at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in AOFAS from Baseline to 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Clarix™1k Graft</title>
          <description>Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.</description>
        </group>
        <group group_id="E2">
          <title>Control Arm Without Clarix™1k Graft</title>
          <description>Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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>Early termination leading to only one subject completing the trial.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Gregory Berlet, MD</name_or_title>
      <organization>Orthopedic Foot and Ankle Center</organization>
      <phone>614-895-8747</phone>
      <email>ofacresearch@orthofootankle.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/NCT01708187
org study id: OH1-12-00396
nct id: NCT01708187
lead sponsor: 
has dmc: No
Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all
      flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal
      tendon gliding is key to their function as effective plantar flexors and evertors of the
      hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction
      at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for
      standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal
      adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing
      Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft
      will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic
      Membrane in conjunction with a peroneal tendon repair will decrease that amount of
      inflammation, overall recovery time of surgically repaired peroneal tendon tears, and
      adhesions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
time frame: Baseline,12 months
description: Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.
VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score
arm group label: Clarix™1k graft
arm group type: Experimental
description: Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
arm group label: Control arm without Clarix™1k graft
arm group type: No Intervention
description: Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.
intervention type: Biological
intervention name: Clarix™1k graft
description: Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.
arm group label: Clarix™1k graft
other name: cryopreserved Human Amniotic Membrane (C-HAM) graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory C Berlet, MD
role: Principal Investigator
affiliation: Orthopedic Foot and Ankle Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Orthopedic Foot and Ankle Center, Ohio
investigator full name: Greg Berlet
investigator title: MD
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to only one subject completing the trial.
point of contact: 