<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/NCT01691950</url>
  </required_header>
  <id_info>
    <org_study_id>CRO1934</org_study_id>
    <nct_id>NCT01691950</nct_id>
  </id_info>
  <brief_title>Investigating Outcomes of Lower Limb Trauma</brief_title>
  <official_title>Investigating the Outcomes of Lower-limb Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Engineering and Physical Sciences Research Council, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</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>
      This is an observational study, which aims to firstly develop a sensor-based objective&#xD;
      mobility assessment. This will then be used to profile and compare the outcomes of patients&#xD;
      who undergo amputation with those who have limb salvage surgery following a traumatic injury&#xD;
      to their lower limb.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the setting of severe trauma, the decision whether to amputate or save a limb is common,&#xD;
      and extremely difficult to make. Due to improving reconstructive surgical techniques there&#xD;
      are currently no clear criteria for amputation. Although limb salvage appears desirable in&#xD;
      most situations, numerous articles in the scientific literature have shown that it is&#xD;
      associated with increased pain, complications, duration of hospital stay, rehabilitation&#xD;
      time, and overall costs. These factors may be acceptable if the patients benefited from&#xD;
      improved functional outcome. However, studies comparing amputation to limb salvage&#xD;
      consistently report no significant difference in functional outcome between the two groups.&#xD;
&#xD;
      A major limitation in the methodology of the fore mentioned studies is the use of&#xD;
      self-reported questionnaires to determine functional outcome. Questionnaires are subjective,&#xD;
      and often lack specificity, and therefore may not be truly representative of functional&#xD;
      outcome. Furthermore, lack of useful information during long-term post-operative care&#xD;
      prevents adaption and optimisation of rehabilitation strategies.&#xD;
&#xD;
      The investigators plan on using a wearable sensor to develop an objective mobility assessment&#xD;
      tool for patients having either amputation or limb salvage surgery after lower limb trauma.&#xD;
      This would result in a reliable and accurate comparison, which may help healthcare&#xD;
      professionals make an informed decision between amputation and limb salvage in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)</measure>
    <time_frame>3 months post-reconstruction</time_frame>
    <description>The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant Length of Hospital Stay</measure>
    <time_frame>Up to length of study (1-2 years)</time_frame>
    <description>These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Reconstruction</arm_group_label>
    <description>Those who have undergone limb reconstruction following lower limb trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Healthy volunteers for control</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who have been treated following lower limb trauma at the Imperial College NHS&#xD;
        Trust sites will be recruited for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation&#xD;
             with fitting of prosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contralateral (or other) limb impairment&#xD;
&#xD;
          2. 18 &gt; AGE &gt; 65&#xD;
&#xD;
          3. Currently a hospital inpatient&#xD;
&#xD;
          4. Psychological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard M Kwasnicki, BSc (Hons)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shehan Hettiaratchy, PhD, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imperial College NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>April 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>February 21, 2019</results_first_submitted>
  <results_first_submitted_qc>August 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 20, 2019</results_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trauma</keyword>
  <keyword>Limb reconstruction</keyword>
  <keyword>Amputation</keyword>
  <keyword>Functional outcome</keyword>
  <keyword>Sensing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Reconstruction</title>
          <description>Those who have undergone limb reconstruction following lower limb trauma</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Healthy volunteers</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reconstruction</title>
          <description>Those who have undergone limb reconstruction following lower limb trauma</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Healthy volunteers</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="20"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.3" spread="15.8"/>
                    <measurement group_id="B2" value="34.7" spread="12.9"/>
                    <measurement group_id="B3" value="36.5" spread="14.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)</title>
        <description>The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.</description>
        <time_frame>3 months post-reconstruction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reconstruction</title>
            <description>Those who have undergone limb reconstruction following lower limb trauma</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Healthy volunteers</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)</title>
          <description>The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="13.9"/>
                    <measurement group_id="O2" value="58.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Length of Hospital Stay</title>
        <description>These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions.</description>
        <time_frame>Up to length of study (1-2 years)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Reconstruction</title>
          <description>Those who have undergone limb reconstruction following lower limb trauma</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Healthy volunteers</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>The trial recruited 0 patients with prostheses and as such this study arm has been deleted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Mr Richard M Kwasnicki PhD MRCS</name_or_title>
      <organization>Imperial College London</organization>
      <phone>+44 (0) 20 759 48904</phone>
      <email>rmk107@ic.ac.uk</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/NCT01691950
org study id: CRO1934
nct id: NCT01691950
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational study, which aims to firstly develop a sensor-based objective
      mobility assessment. This will then be used to profile and compare the outcomes of patients
      who undergo amputation with those who have limb salvage surgery following a traumatic injury
      to their lower limb.
In the setting of severe trauma, the decision whether to amputate or save a limb is common,
      and extremely difficult to make. Due to improving reconstructive surgical techniques there
      are currently no clear criteria for amputation. Although limb salvage appears desirable in
      most situations, numerous articles in the scientific literature have shown that it is
      associated with increased pain, complications, duration of hospital stay, rehabilitation
      time, and overall costs. These factors may be acceptable if the patients benefited from
      improved functional outcome. However, studies comparing amputation to limb salvage
      consistently report no significant difference in functional outcome between the two groups.

      A major limitation in the methodology of the fore mentioned studies is the use of
      self-reported questionnaires to determine functional outcome. Questionnaires are subjective,
      and often lack specificity, and therefore may not be truly representative of functional
      outcome. Furthermore, lack of useful information during long-term post-operative care
      prevents adaption and optimisation of rehabilitation strategies.

      The investigators plan on using a wearable sensor to develop an objective mobility assessment
      tool for patients having either amputation or limb salvage surgery after lower limb trauma.
      This would result in a reliable and accurate comparison, which may help healthcare
      professionals make an informed decision between amputation and limb salvage in the future.
observational model: Cohort
time perspective: Other
measure: Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)
time frame: 3 months post-reconstruction
description: The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.
measure: Participant Length of Hospital Stay
time frame: Up to length of study (1-2 years)
description: These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions.
arm group label: Reconstruction
description: Those who have undergone limb reconstruction following lower limb trauma
arm group label: Healthy volunteers
description: Healthy volunteers for control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard M Kwasnicki, BSc (Hons)
role: Principal Investigator
affiliation: Imperial College London
last name: Shehan Hettiaratchy, PhD, FRCS
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The trial recruited 0 patients with prostheses and as such this study arm has been deleted.
point of contact: 