<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/NCT01703182</url>
  </required_header>
  <id_info>
    <org_study_id>TCOM-2012</org_study_id>
    <nct_id>NCT01703182</nct_id>
  </id_info>
  <brief_title>Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations</brief_title>
  <acronym>TCOM</acronym>
  <official_title>Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations - An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations.&#xD;
      Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30&#xD;
      minutes before their surgery and will be followed up until 6 months after their surgery. The&#xD;
      purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide&#xD;
      measurements in the legs of patients undergoing lower limb amputation to predict wound&#xD;
      healing complications and to determine an optimum cutoff value for both oxygen and carbon&#xD;
      dioxide levels beyond which healing complications are likely to occur and a closer amputation&#xD;
      level is indicated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lower limb amputation is a serious and unfortunate outcome for many patients with vascular&#xD;
      disease, especially those with diabetes. It results in significant decreases in all aspects&#xD;
      of quality of life. The need for further surgery to revise the amputation to a more proximal&#xD;
      level leads to increased potential for serious and life-threatening complications, as well as&#xD;
      a decrease in patient morale. From surveys and background literature, it can be estimated&#xD;
      that there are approximately 8600 vascular disease-related lower limb amputations in Canada&#xD;
      each year. As the epidemic of diabetes continues to unfold and the mean age of the population&#xD;
      increases, this number is expected to increase. The results of this study may significantly&#xD;
      assist in the surgical and clinical care of this patient population by providing clinicians&#xD;
      with a means to assess appropriate lower limb amputation levels.&#xD;
&#xD;
      Further, the modalities of transcutaneous measures may assist in guiding further intervention&#xD;
      studies in higher risk patients to improve clinically important outcomes. This study will act&#xD;
      in part as a feasibility trial for a randomized controlled trial assessing the efficacy of&#xD;
      supplemental oxygen therapy, including hyperbaric oxygen therapy, as a therapeutic tool to&#xD;
      increase rates of healing after lower limb amputation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped due to feasibility&#xD;
  </why_stopped>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">February 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of all-cause 30-day mortality and healing failure of the surgical stump</measure>
    <time_frame>30 days post-surgery</time_frame>
    <description>Composite of all-cause 30-day mortality and healing failure of the surgical stump at 30 days postoperatively, defined as the need for amputation revision.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-month all-cause mortality.</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>6-month all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-amputation from 30 days to 6 months post-amputation</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Incidence of re-amputation from 30 days to 6 months post-amputation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of prosthesis for mobilization within 6 months post-amputation</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Use of prosthesis for mobilization within 6 months post-amputation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life from baseline at 6-months post-amputation</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Change in health-related quality of life from baseline at 6-months post-amputation, based on the quality of life questionnaire (EuroQoL-5D)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Amputation Wound</condition>
  <arm_group>
    <arm_group_label>leg amputation</arm_group_label>
    <description>Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing below-knee and above-ankle amputations due to vascular complications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Requires a lower limb amputation between the ankle and knee due to vascular&#xD;
             complications&#xD;
&#xD;
          3. Provides written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Requires a lower limb amputation for non-vascular reasons, including trauma and cancer&#xD;
&#xD;
          2. Requires primary amputation below the level of the ankle or above the knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Whitlock, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Richard Whitlock</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>transcutaneous oximetry</keyword>
  <keyword>transcutaneous carbon dioxide</keyword>
  <keyword>leg amputation</keyword>
  <keyword>wound healing failure</keyword>
  <keyword>amputation revision</keyword>
  <!-- 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/NCT01703182
org study id: TCOM-2012
nct id: NCT01703182
lead sponsor: 
collaborator: 
has dmc: No
TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations.
      Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30
      minutes before their surgery and will be followed up until 6 months after their surgery. The
      purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide
      measurements in the legs of patients undergoing lower limb amputation to predict wound
      healing complications and to determine an optimum cutoff value for both oxygen and carbon
      dioxide levels beyond which healing complications are likely to occur and a closer amputation
      level is indicated.
Lower limb amputation is a serious and unfortunate outcome for many patients with vascular
      disease, especially those with diabetes. It results in significant decreases in all aspects
      of quality of life. The need for further surgery to revise the amputation to a more proximal
      level leads to increased potential for serious and life-threatening complications, as well as
      a decrease in patient morale. From surveys and background literature, it can be estimated
      that there are approximately 8600 vascular disease-related lower limb amputations in Canada
      each year. As the epidemic of diabetes continues to unfold and the mean age of the population
      increases, this number is expected to increase. The results of this study may significantly
      assist in the surgical and clinical care of this patient population by providing clinicians
      with a means to assess appropriate lower limb amputation levels.

      Further, the modalities of transcutaneous measures may assist in guiding further intervention
      studies in higher risk patients to improve clinically important outcomes. This study will act
      in part as a feasibility trial for a randomized controlled trial assessing the efficacy of
      supplemental oxygen therapy, including hyperbaric oxygen therapy, as a therapeutic tool to
      increase rates of healing after lower limb amputation.
observational model: Cohort
time perspective: Prospective
measure: Composite of all-cause 30-day mortality and healing failure of the surgical stump
time frame: 30 days post-surgery
description: Composite of all-cause 30-day mortality and healing failure of the surgical stump at 30 days postoperatively, defined as the need for amputation revision.
measure: 6-month all-cause mortality.
time frame: 6 months post-surgery
description: 6-month all-cause mortality
measure: Incidence of re-amputation from 30 days to 6 months post-amputation
time frame: 6 months post-surgery
description: Incidence of re-amputation from 30 days to 6 months post-amputation
measure: Use of prosthesis for mobilization within 6 months post-amputation
time frame: 6 months post-surgery
description: Use of prosthesis for mobilization within 6 months post-amputation
measure: Change in health-related quality of life from baseline at 6-months post-amputation
time frame: 6 months post-surgery
description: Change in health-related quality of life from baseline at 6-months post-amputation, based on the quality of life questionnaire (EuroQoL-5D)
arm group label: leg amputation
description: Patients undergoing below-knee and above ankle amputation for vascular reasons will receive transcutaneous oximetry and transcutaneous carbon dioxide measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Whitlock, MD, FRCPC
role: Principal Investigator
affiliation: Population Health Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Richard Whitlock
investigator title: Assistant Professor