<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/NCT01678001</url>
  </required_header>
  <id_info>
    <org_study_id>MRZ IIT - 2011 - 009</org_study_id>
    <nct_id>NCT01678001</nct_id>
  </id_info>
  <brief_title>Treatment of Plantar Fasciitis With Xeomin</brief_title>
  <acronym>Xeomin</acronym>
  <official_title>Treatment of Plantar Fasciitis With Xeomin: A Randomized, Placebo-Controlled, Double-Blinded, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rothman Institute Orthopaedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merz North America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rothman Institute Orthopaedics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of&#xD;
      the foot.&#xD;
&#xD;
      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.&#xD;
&#xD;
      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical&#xD;
      treatment modalities. Surgical treatment of plantar fasciitis is indicated only if&#xD;
      nonsurgical means fail.&#xD;
&#xD;
      A newer method of treating plantar fasciitis before resorting to surgery is the use of&#xD;
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis&#xD;
      with Xeomin is important, as there are limited studies on the subject to date. The purpose of&#xD;
      this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in&#xD;
      one physician's (J.A.) practice at Rothman Institute Orthopaedics through a&#xD;
      placebo-controlled, randomized, double-blinded study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of&#xD;
      the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar&#xD;
      surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It&#xD;
      also helps with shock absorption upon weight bearing activities such as walking and running.&#xD;
&#xD;
      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.&#xD;
      This inflammation is often caused by over activity, improper shoes, flat feet, or excessive&#xD;
      weight on the feet.&#xD;
&#xD;
      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical&#xD;
      treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or&#xD;
      inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment&#xD;
      of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have&#xD;
      risks, which include but are not limited to bleeding, infection, and nerve injury.&#xD;
&#xD;
      A newer method of treating plantar fasciitis before resorting to surgery is the use of&#xD;
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via&#xD;
      direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts&#xD;
      up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for&#xD;
      treating spastic muscles. However, others provide single injections to help achieve a&#xD;
      specific goal.&#xD;
&#xD;
      Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the&#xD;
      subject to date. Much of the existing research involves BoTox A and non-controlled studies&#xD;
      with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled,&#xD;
      randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this&#xD;
      study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term&#xD;
      results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at&#xD;
      Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Function</measure>
    <time_frame>1 year</time_frame>
    <description>Function will be scored primarily according to the Foot and Ankle Ability Measure (FAAM), which is validated and reproducible. Scores are based on standing, walking, and performing activities of daily living (ADLs). The scores are between 0 points for being completely disabled and 100 points for being totally without symptoms. A score of 90 or more indicates an excellent result. The PI will gather scores before and after injection. These FAAM scores will be gathered at the time of outpatient follow-up and used to evaluate the final outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>1 year</time_frame>
    <description>Patients' pain will be scored with a 10 cm visual analog scale (VAS). If applicable, progression to surgical treatment will also be documented.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will be asked about their satisfaction by using a CGI satisfaction scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Plantar Fascitis</condition>
  <arm_group>
    <arm_group_label>Xeomin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xeomin</intervention_name>
    <description>Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Xeomin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects will be adults above the age of 18 years of any gender or race.&#xD;
&#xD;
          2. Subjects' diagnosis will be plantar fasciitis.&#xD;
&#xD;
          3. Subjects should have attempted 6 weeks of nonsurgical treatment and failed prior to&#xD;
             injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects must not have a normal plantar fascia.&#xD;
&#xD;
          2. Subjects must not have received previous BoTox injections at their plantar fascia.&#xD;
&#xD;
          3. Subjects must have not have received prior surgery on their plantar fascia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jamal Ahmad, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rothman Institute Orthopaedics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rothman Institute Orthopaedics</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rothman Institute Orthopaedics</investigator_affiliation>
    <investigator_full_name>Jamal Ahmad</investigator_full_name>
    <investigator_title>Assistant Professor of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>plantar fascia</keyword>
  <keyword>plantar fascitis</keyword>
  <keyword>botulinum toxin</keyword>
  <keyword>Xeomin</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>incobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01678001
org study id: MRZ IIT - 2011 - 009
nct id: NCT01678001
lead sponsor: 
collaborator: 
has dmc: No
The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of
      the foot.

      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.

      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical
      treatment modalities. Surgical treatment of plantar fasciitis is indicated only if
      nonsurgical means fail.

      A newer method of treating plantar fasciitis before resorting to surgery is the use of
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis
      with Xeomin is important, as there are limited studies on the subject to date. The purpose of
      this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in
      one physician's (J.A.) practice at Rothman Institute Orthopaedics through a
      placebo-controlled, randomized, double-blinded study.
The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of
      the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar
      surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It
      also helps with shock absorption upon weight bearing activities such as walking and running.

      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.
      This inflammation is often caused by over activity, improper shoes, flat feet, or excessive
      weight on the feet.

      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical
      treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or
      inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment
      of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have
      risks, which include but are not limited to bleeding, infection, and nerve injury.

      A newer method of treating plantar fasciitis before resorting to surgery is the use of
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via
      direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts
      up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for
      treating spastic muscles. However, others provide single injections to help achieve a
      specific goal.

      Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the
      subject to date. Much of the existing research involves BoTox A and non-controlled studies
      with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled,
      randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this
      study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term
      results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at
      Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Function
time frame: 1 year
description: Function will be scored primarily according to the Foot and Ankle Ability Measure (FAAM), which is validated and reproducible. Scores are based on standing, walking, and performing activities of daily living (ADLs). The scores are between 0 points for being completely disabled and 100 points for being totally without symptoms. A score of 90 or more indicates an excellent result. The PI will gather scores before and after injection. These FAAM scores will be gathered at the time of outpatient follow-up and used to evaluate the final outcome.
measure: Pain
time frame: 1 year
description: Patients' pain will be scored with a 10 cm visual analog scale (VAS). If applicable, progression to surgical treatment will also be documented.
measure: Satisfaction
time frame: 1 year
description: Patients will be asked about their satisfaction by using a CGI satisfaction scale.
arm group label: Xeomin
arm group type: Active Comparator
description: Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
arm group label: Placebo
arm group type: Placebo Comparator
description: Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
intervention type: Drug
intervention name: Xeomin
description: Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
arm group label: Placebo
arm group label: Xeomin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jamal Ahmad, M.D.
role: Principal Investigator
affiliation: Rothman Institute Orthopaedics
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rothman Institute Orthopaedics
investigator full name: Jamal Ahmad
investigator title: Assistant Professor of Orthopaedic Surgery
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
mesh term: incobotulinumtoxinA