<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/NCT02982226</url>
  </required_header>
  <id_info>
    <org_study_id>RD-2015-08-05</org_study_id>
    <nct_id>NCT02982226</nct_id>
  </id_info>
  <brief_title>ReNu™ vs. Corticosteroids for the Treatment of Plantar Fasciitis</brief_title>
  <official_title>A Comparative Study of Injectable Human Amniotic Allograft (ReNu™) Versus Corticosteroids for Plantar Fasciitis: A Prospective, Randomized, Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuTech Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MileStone Research Organization</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Organogenesis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NuTech Medical, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™&#xD;
      injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared&#xD;
      to a Corticosteroid Injection which is considered standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be&#xD;
      treated with ReNu™(study treatment) or Corticosteroids (control).&#xD;
&#xD;
      At each follow-up visit, concomitant medications and adverse events shall be collected from&#xD;
      each subject, and each subject shall complete following questionnaires:&#xD;
&#xD;
        -  AOFAS Ankle-Hindfoot Score (AOFAS-AHS)&#xD;
&#xD;
        -  Visual Analog Score (VAS)&#xD;
&#xD;
        -  Single Answer Numeric Evaluation (SANE)&#xD;
&#xD;
        -  Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)&#xD;
&#xD;
      The subjects will be assessed at Baseline (pre-injection) using these scales and again at all&#xD;
      subsequent study follow-up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in AOFAS score from baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in VAS pain score from baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SANE function score from baseline</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to Normal Function between treatment groups</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed using questionnaire by the Principal Investigator (PI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Fasciitis, Plantar</condition>
  <arm_group>
    <arm_group_label>ReNu Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plantar Fascia injection with Corticosteroids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ReNu Injection</intervention_name>
    <description>ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.</description>
    <arm_group_label>ReNu Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Corticosteroid Injection</intervention_name>
    <description>Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis</description>
    <arm_group_label>Corticosteroid Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages 18 to 75 inclusive&#xD;
&#xD;
          2. BMI less than 40&#xD;
&#xD;
          3. Actively practicing a contraception method, abstinent, surgically sterile, or&#xD;
             post-menopausal (defined as no menses for a minimum of 12 months)&#xD;
&#xD;
          4. Reporting heel pain of &gt;6 on a verbally administered 1-10 pain scale where 1 is no&#xD;
             pain and 10 is extreme pain&#xD;
&#xD;
          5. Diagnosed with plantar fasciitis in either foot&#xD;
&#xD;
          6. Completed a minimum of two months of conservative, non-injection treatment/therapies&#xD;
             (i.e., activity modification, icing, NSAIDs, orthotics, physical therapy, etc.)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Prior surgery on the affected foot&#xD;
&#xD;
          2. Prior injection treatment for plantar fasciitis within the past 6 months with steroids&#xD;
             or tissue engineered materials just in the site seeking treatment&#xD;
&#xD;
          3. Clinical signs and symptoms of infection of foot in question&#xD;
&#xD;
          4. Evidence of significant neurological disease of either foot&#xD;
&#xD;
          5. Non-ambulatory&#xD;
&#xD;
          6. Presence of comorbidities that can be confused with or can exacerbate the condition&#xD;
             including, but not limited to the following:&#xD;
&#xD;
               -  Calcaneal stress fracture&#xD;
&#xD;
               -  Nerve entrapment syndrome, such as Baxter's Nerve Entrapment or Tarsal Tunnel&#xD;
                  Syndrome&#xD;
&#xD;
               -  Plantar Fascial rupture&#xD;
&#xD;
               -  Systemic disorders associated with enthesiopathy, i.e., Gout, Reiter's syndrome,&#xD;
                  rheumatoid arthritis, etc.&#xD;
&#xD;
               -  Achilles tendonitis&#xD;
&#xD;
               -  Fat Pad Atrophy&#xD;
&#xD;
               -  Fibromyalgia&#xD;
&#xD;
               -  Diabetic Neuropathy&#xD;
&#xD;
          7. Pregnant, pregnant within the past six (6) months, breast feeding and/or desire to&#xD;
             become pregnant during the course of the study, as verified by urine pregnancy test&#xD;
             within one week prior to injection.&#xD;
&#xD;
          8. Has taken NSAID medication within the past 14 days, or other pain medication in the&#xD;
             past day&#xD;
&#xD;
          9. 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 has receive such medications during the screening period, or are&#xD;
             anticipated to require such medications during the course of the study.&#xD;
&#xD;
         10. Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding&#xD;
             screening&#xD;
&#xD;
         11. History of radiation therapy of the affected foot&#xD;
&#xD;
         12. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV&#xD;
&#xD;
         13. Involved in a Worker's Compensation Claim of any kind&#xD;
&#xD;
         14. Unable to understand the objectives of the trial&#xD;
&#xD;
         15. 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;
         16. Having a known history of poor adherence with medical treatment.&#xD;
&#xD;
         17. Express an unwillingness to receive human allograft tissue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Ng, DPM, FACFAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Orthopedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Orthopedics</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Food and Ankle Clinic</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Iowa Clinic Foot and Ankle Surgery</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lower Extremity Institute of Research &amp; Therapy (LEIRT)</name>
      <address>
        <city>Poland</city>
        <state>Ohio</state>
        <zip>44514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vancouvover Clinic</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plantar Fasciitis</keyword>
  <keyword>Jogger's Heel</keyword>
  <keyword>ReNu</keyword>
  <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>
  <!-- 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/NCT02982226
org study id: RD-2015-08-05
nct id: NCT02982226
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this clinical trial is to evaluate both the safety and efficacy of the ReNu™
      injection on pain and inflammation in subjects diagnosed with plantar fasciitis as compared
      to a Corticosteroid Injection which is considered standard of care.
This is a two (2) arm evaluation in 150 subjects with plantar fasciitis. Patients will be
      treated with ReNu™(study treatment) or Corticosteroids (control).

      At each follow-up visit, concomitant medications and adverse events shall be collected from
      each subject, and each subject shall complete following questionnaires:

        -  AOFAS Ankle-Hindfoot Score (AOFAS-AHS)

        -  Visual Analog Score (VAS)

        -  Single Answer Numeric Evaluation (SANE)

        -  Subject Satisfaction Score (at the 6 Month Follow Ups ONLY)

      The subjects will be assessed at Baseline (pre-injection) using these scales and again at all
      subsequent study follow-up visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in AOFAS score from baseline
time frame: 6 months
measure: Change in VAS pain score from baseline
time frame: 6 months
measure: Change in SANE function score from baseline
time frame: 6 months
measure: Return to Normal Function between treatment groups
time frame: 6 months
description: Assessed using questionnaire by the Principal Investigator (PI)
arm group label: ReNu Injection
arm group type: Experimental
description: Plantar Fascia injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
arm group label: Corticosteroid Injection
arm group type: Active Comparator
description: Plantar Fascia injection with Corticosteroids.
intervention type: Other
intervention name: ReNu Injection
description: ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
arm group label: ReNu Injection
intervention type: Other
intervention name: Corticosteroid Injection
description: Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis
arm group label: Corticosteroid Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Alan Ng, DPM, FACFAS
role: Principal Investigator
affiliation: Advanced Orthopedics
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No