<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/NCT03828916</url>
  </required_header>
  <id_info>
    <org_study_id>RD2018-01-01</org_study_id>
    <nct_id>NCT03828916</nct_id>
  </id_info>
  <brief_title>NuShield in Surgical Peroneal Tendon Repair</brief_title>
  <official_title>Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuTech Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Organogenesis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NuTech Medical, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical&#xD;
      tendon repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this clinical trial is to evaluate both the safety and efficacy of using the&#xD;
      NuShield® allograft in addition to standard of care surgical procedures in subjects requiring&#xD;
      surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:&#xD;
&#xD;
        -  Questionnaires&#xD;
&#xD;
             -  Visual Analog Scale Foot and Ankle (VAS FA)&#xD;
&#xD;
             -  FAAM Sport&#xD;
&#xD;
             -  PROMIS Global Health SF&#xD;
&#xD;
             -  Tegner Activity Scale&#xD;
&#xD;
             -  Foot and Ankle Outcomes Instrument (Q1, Q2)&#xD;
&#xD;
        -  Swelling assessments&#xD;
&#xD;
        -  Ultrasound imaging for tendon thickness, gliding and adhesion formation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS Foot and Ankle Pain</measure>
    <time_frame>6 Months</time_frame>
    <description>Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAAM Sports Subscale</measure>
    <time_frame>6 Months</time_frame>
    <description>Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling assessment by investigator</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Circumferential measurement of the limbs. Change in swelling measured in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Global Health Subscale</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>PROMIS® (Patient-Reported Outcomes Measurement Information System) Global Health Subscale. Changes from baseline (scale 1-5); with 5 indicating better outcomes and 1 indicating worse outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tegner Activity Scale</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tendon Injuries</condition>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>NuShield</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NuShield</intervention_name>
    <description>SOC surgery with the addition of NuShield</description>
    <arm_group_label>NuShield</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18 to 60 inclusive&#xD;
&#xD;
          -  If female, actively practicing a medically relevant method of contraception,&#xD;
             abstinent, surgically sterile, or post-menopausal (defined as no menses for at least&#xD;
             12 months)&#xD;
&#xD;
          -  Have a diagnosis of one of the following in relation to the peroneal tendon:&#xD;
&#xD;
               -  Tendonitis with MRI confirmation&#xD;
&#xD;
               -  Synovial inflammation&#xD;
&#xD;
               -  Tear&#xD;
&#xD;
          -  Diagnosis resulting from acute injury to the tendon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI equal to or greater than 35&#xD;
&#xD;
          -  Prior injury to the peroneal tendon&#xD;
&#xD;
          -  Collagen disorders&#xD;
&#xD;
          -  Inflammatory arteriopathies&#xD;
&#xD;
          -  Immune compromised&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Less than 6 months between injury and proposed surgery date&#xD;
&#xD;
          -  Steroid injection within the past 6 weeks localized to the treatment area&#xD;
&#xD;
          -  Pregnant within the past six (6) months, breast feeding and/or desire to become&#xD;
             pregnant during the course of the study, as verified by urine pregnancy test within&#xD;
             one week prior to treatment&#xD;
&#xD;
          -  History of more than two (2) weeks treatment with immuno-suppressants, including&#xD;
             systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial&#xD;
             screening, or have received such medications during the screening period, or are&#xD;
             anticipated to require such medications during the course of the study&#xD;
&#xD;
          -  Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding&#xD;
             screening&#xD;
&#xD;
          -  History of radiation therapy of the affected foot&#xD;
&#xD;
          -  Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV&#xD;
&#xD;
          -  Currently involved in medical litigation, including Worker's Compensation claims of&#xD;
             any type&#xD;
&#xD;
          -  Unable to understand the objectives of the trial&#xD;
&#xD;
          -  Presence of any condition(s) which, in the opinion of the investigator, would&#xD;
             compromise the subject's ability to complete this study&#xD;
&#xD;
          -  Having a known history of poor adherence with medical treatment&#xD;
&#xD;
          -  Express an unwillingness to receive human allograft tissue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katie Mowry</last_name>
    <phone>205-800-8301</phone>
    <email>kmowry@organo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Central Research Associates, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shannon Helton, RN</last_name>
      <phone>205-327-1077</phone>
      <email>shannon@centraltrials.com</email>
    </contact>
    <investigator>
      <last_name>Norman Waldrop, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>720-848-1900</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tendon Surgery</keyword>
  <keyword>NuShield</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Tendon Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828916
org study id: RD2018-01-01
nct id: NCT03828916
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical
      tendon repair.
The objective of this clinical trial is to evaluate both the safety and efficacy of using the
      NuShield® allograft in addition to standard of care surgical procedures in subjects requiring
      surgical repair of the peroneal tendon. The effects of this treatment will be assessed using:

        -  Questionnaires

             -  Visual Analog Scale Foot and Ankle (VAS FA)

             -  FAAM Sport

             -  PROMIS Global Health SF

             -  Tegner Activity Scale

             -  Foot and Ankle Outcomes Instrument (Q1, Q2)

        -  Swelling assessments

        -  Ultrasound imaging for tendon thickness, gliding and adhesion formation
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VAS Foot and Ankle Pain
time frame: 6 Months
description: Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome
measure: FAAM Sports Subscale
time frame: 6 Months
description: Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes
measure: Adverse Events
time frame: up to 1 year
description: Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.
measure: Swelling assessment by investigator
time frame: 6 and 12 months
description: Circumferential measurement of the limbs. Change in swelling measured in cm
measure: PROMIS Global Health Subscale
time frame: 6 and 12 months
description: PROMIS® (Patient-Reported Outcomes Measurement Information System) Global Health Subscale. Changes from baseline (scale 1-5); with 5 indicating better outcomes and 1 indicating worse outcomes
measure: Tegner Activity Scale
time frame: 6 and 12 months
description: Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes
measure: Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)
time frame: 6 and 12 months
description: Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes
arm group label: NuShield
arm group type: Other
intervention type: Other
intervention name: NuShield
description: SOC surgery with the addition of NuShield
arm group label: NuShield
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Katie Mowry
phone: 205-800-8301
email: kmowry@organo.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Tendon Injuries
sharing ipd: No