<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/NCT04409600</url>
  </required_header>
  <id_info>
    <org_study_id>WRNMMC-2019-0266</org_study_id>
    <nct_id>NCT04409600</nct_id>
  </id_info>
  <brief_title>Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)</brief_title>
  <official_title>Comparison of Non-Surgical Treatment Options for Chronic Exertional Compartment Syndrome (CECS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uniformed Services University of the Health Sciences</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition&#xD;
      in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional&#xD;
      activity, typically running, that quickly dissipates once the activity stopped. Surgical&#xD;
      fasciotomy is the standard for treating lower leg CECS, but success is variable.&#xD;
      Complications may occur post-surgery and there is a potential for a repeat procedure.&#xD;
      Recovery times post-surgery also vary greatly. Conservative treatments, such as gait&#xD;
      retraining and botulinum toxin injections, are emerging as non-surgical options for the&#xD;
      treatment of CECS with success through published case reports and case series. This study&#xD;
      aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and&#xD;
      lateral leg compartments with a follow up for at least 2 years across multiple study sites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are masked to treatment injection arm. At 3 months post-injection, the treatment injection arm will be revealed to the participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Balance Error Scoring System Score</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-months post injection</time_frame>
    <description>Clinical evaluation tool to assess balance. Individuals are assessed on a firm and flat surface while completing different stances and observed for multiple errors while performing the activity. The higher the number of errors, the greater the deficiency in their balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in University of Wisconsin Running Injury and Recovery Index Score</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>9-item questionnaire that assesses an individual's ability to run after a running related injury. Total maximum score is 36 with higher scores indicating no deficiency in their ability to run.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Single Assessment Numerical Evaluation (SANE)</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function compared to their function prior to their injury, on a scale from 0-100. A higher score suggests a higher level of function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient Specific Functional Scale Scores</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Global Rate of Change Score</measure>
    <time_frame>6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gait analysis</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-months post injection</time_frame>
    <description>Using wearable technology and slow motion capture camera, gait analysis will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ability to return to full active duty</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Question asked to military service members about their ability to return to full active duty.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ability to run 2 miles</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Question asked to military service members about their ability to run 2 miles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain reduction</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual's pain level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to perform service specific military physical training requirements</measure>
    <time_frame>baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Question that asks the military service member of their ability to perform service specific physical training requirements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction of treatment</measure>
    <time_frame>6 weeks, 3-, 6-, 12-, 24-, 36-months post injection</time_frame>
    <description>Questionnaire asking the individual to rate their satisfaction of treatment from 'exceptional' to 'very poor.'</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">620</enrollment>
  <condition>Chronic Exertional Compartment Syndrome</condition>
  <arm_group>
    <arm_group_label>Home Based Gait Retraining + Saline Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Based Gait Retraining + Botulinum Toxin Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised Gait Retraining + Saline Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised Gait Retraining + Botulinum Toxin Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised Gait Retraining</intervention_name>
    <description>The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.</description>
    <arm_group_label>Supervised Gait Retraining + Botulinum Toxin Injection</arm_group_label>
    <arm_group_label>Supervised Gait Retraining + Saline Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Based Gait Retraining</intervention_name>
    <description>The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.</description>
    <arm_group_label>Home Based Gait Retraining + Botulinum Toxin Injection</arm_group_label>
    <arm_group_label>Home Based Gait Retraining + Saline Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Injection</intervention_name>
    <description>The participant will receive a saline injection to their painful lower leg compartment(s).</description>
    <arm_group_label>Home Based Gait Retraining + Saline Injection</arm_group_label>
    <arm_group_label>Supervised Gait Retraining + Saline Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Injection</intervention_name>
    <description>The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).</description>
    <arm_group_label>Home Based Gait Retraining + Botulinum Toxin Injection</arm_group_label>
    <arm_group_label>Supervised Gait Retraining + Botulinum Toxin Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty service&#xD;
&#xD;
          -  Fluent in speaking and reading English&#xD;
&#xD;
          -  Unable to run 2 miles without producing pain and/or symptoms&#xD;
&#xD;
          -  Difficulty completing the running portion of their service-specific physical training&#xD;
             due to pain and/or symptoms in their lower leg&#xD;
&#xD;
          -  Meets clinical diagnostic criteria for CECS of the anterior or lateral compartment per&#xD;
             clinical examination (palpation, intramuscular compartment pressure, lower leg MRI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior botulinum injection in the lower leg compartment of the affected limb&#xD;
&#xD;
          -  Prior compartment release of affected lower leg&#xD;
&#xD;
          -  Recent (within the last 6 months) lower limb injury that needed medical intervention&#xD;
&#xD;
          -  Completed formal gait retraining within the last 6 months&#xD;
&#xD;
          -  Allergic to botulinum toxin&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Medical examination that indicates a condition other than CECS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Leggit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uniformed Services University of the Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeffrey Leggit, MD</last_name>
    <phone>301-295-9460</phone>
    <email>jeff.leggit@usuhs.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Teonette Velasco, DPT</last_name>
    <phone>301-400-4456</phone>
    <email>teonette.velasco.ctr@usuhs.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20307</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeffrey Leggit</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Womack Army Medical Center</name>
      <address>
        <city>Fort Bragg</city>
        <state>North Carolina</state>
        <zip>28310</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carl R. Darnell Army Medical Center</name>
      <address>
        <city>Killeen</city>
        <state>Texas</state>
        <zip>76544</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Hoellen, ATC</last_name>
      <email>david.hoellen.ctr@usuhs.edu</email>
    </contact>
    <investigator>
      <last_name>Caleb Dickison, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fort Belvoir Community Hospital</name>
      <address>
        <city>Fort Belvoir</city>
        <state>Virginia</state>
        <zip>22060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katie Roberts, ATC, DHSc</last_name>
      <email>kathryn.roberts.ctr@usuhs.edu</email>
    </contact>
    <investigator>
      <last_name>Chad Hulsopple, LTC, MC, USA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Fort Lewis</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>botulinum toxin, gait training, military</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compartment Syndromes</mesh_term>
    <mesh_term>Chronic Exertional Compartment Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <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>July 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT04409600/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04409600
org study id: WRNMMC-2019-0266
nct id: NCT04409600
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Chronic Exertional Compartment Syndrome (CECS) in the lower leg is a debilitating condition
      in highly active individuals. Pain occurs in 1 or several leg compartments upon an exertional
      activity, typically running, that quickly dissipates once the activity stopped. Surgical
      fasciotomy is the standard for treating lower leg CECS, but success is variable.
      Complications may occur post-surgery and there is a potential for a repeat procedure.
      Recovery times post-surgery also vary greatly. Conservative treatments, such as gait
      retraining and botulinum toxin injections, are emerging as non-surgical options for the
      treatment of CECS with success through published case reports and case series. This study
      aims to evaluate the use of these non-surgical treatment options for CECS in the anterior and
      lateral leg compartments with a follow up for at least 2 years across multiple study sites.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants are masked to treatment injection arm. At 3 months post-injection, the treatment injection arm will be revealed to the participant.
measure: Change in Balance Error Scoring System Score
time frame: baseline, 6 weeks, 3-, 6-, 12-months post injection
description: Clinical evaluation tool to assess balance. Individuals are assessed on a firm and flat surface while completing different stances and observed for multiple errors while performing the activity. The higher the number of errors, the greater the deficiency in their balance.
measure: Change in University of Wisconsin Running Injury and Recovery Index Score
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: 9-item questionnaire that assesses an individual's ability to run after a running related injury. Total maximum score is 36 with higher scores indicating no deficiency in their ability to run.
measure: Change in Single Assessment Numerical Evaluation (SANE)
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: A patient reported outcome measure consisting of 1 question that asks the individual to rate their current level of function compared to their function prior to their injury, on a scale from 0-100. A higher score suggests a higher level of function.
measure: Change in Patient Specific Functional Scale Scores
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Individuals are asked to self-assess limited activities and measure them on a scale from 0-10 where '0' indicates they are able to perform the activity and '10' indicates that they are unable to perform the activity prior to their condition.
measure: Change in Global Rate of Change Score
time frame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Using a 15 point scale, the individual selects 1 choice to reflect their current perceived health rating compared to a specified time point.
measure: Change in gait analysis
time frame: baseline, 6 weeks, 3-, 6-, 12-months post injection
description: Using wearable technology and slow motion capture camera, gait analysis will be collected.
measure: Change in ability to return to full active duty
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Question asked to military service members about their ability to return to full active duty.
measure: Change in ability to run 2 miles
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Question asked to military service members about their ability to run 2 miles.
measure: Pain reduction
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Pain reduction will be assessed using a numeric pain rating scale (NPRS). This is an 11 point Likert scale that reflects the individual's pain level.
measure: Ability to perform service specific military physical training requirements
time frame: baseline, 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Question that asks the military service member of their ability to perform service specific physical training requirements.
measure: Patient satisfaction of treatment
time frame: 6 weeks, 3-, 6-, 12-, 24-, 36-months post injection
description: Questionnaire asking the individual to rate their satisfaction of treatment from 'exceptional' to 'very poor.'
arm group label: Home Based Gait Retraining + Saline Injection
arm group type: Active Comparator
arm group label: Home Based Gait Retraining + Botulinum Toxin Injection
arm group type: Experimental
arm group label: Supervised Gait Retraining + Saline Injection
arm group type: Active Comparator
arm group label: Supervised Gait Retraining + Botulinum Toxin Injection
arm group type: Experimental
intervention type: Behavioral
intervention name: Supervised Gait Retraining
description: The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
arm group label: Supervised Gait Retraining + Botulinum Toxin Injection
arm group label: Supervised Gait Retraining + Saline Injection
intervention type: Behavioral
intervention name: Home Based Gait Retraining
description: The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
arm group label: Home Based Gait Retraining + Botulinum Toxin Injection
arm group label: Home Based Gait Retraining + Saline Injection
intervention type: Drug
intervention name: Saline Injection
description: The participant will receive a saline injection to their painful lower leg compartment(s).
arm group label: Home Based Gait Retraining + Saline Injection
arm group label: Supervised Gait Retraining + Saline Injection
intervention type: Drug
intervention name: Botulinum Toxin Injection
description: The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
arm group label: Home Based Gait Retraining + Botulinum Toxin Injection
arm group label: Supervised Gait Retraining + Botulinum Toxin Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jeffrey Leggit, MD
role: Principal Investigator
affiliation: Uniformed Services University of the Health Sciences
last name: Jeffrey Leggit, MD
phone: 301-295-9460
email: jeff.leggit@usuhs.edu
last name: Teonette Velasco, DPT
phone: 301-400-4456
email: teonette.velasco.ctr@usuhs.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
country: United States
responsible party type: Sponsor
mesh term: Compartment Syndromes
mesh term: Chronic Exertional Compartment Syndrome
mesh term: Syndrome
mesh term: Botulinum Toxins
provided document: 