xml: <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/NCT06011447</url>
    </required_header>
    <id_info>
      <org_study_id>VS20/130302</org_study_id>
      <nct_id>NCT06011447</nct_id>
    </id_info>
    <brief_title>Laser Speckle Imaging in Ischaemic Tissue Loss</brief_title>
    <official_title>The Use of Laser Speckle Imaging in the Evaluation of Successful Revascularisation of Patients With Ischemic Tissue Loss</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Leeds Teaching Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Leeds Teaching Hospitals NHS Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Peripheral arterial disease is a condition in which the arteries become narrowed due to a&#xD;
        build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and&#xD;
        this can compromise the parts of the body supplied by these arteries. In its most severe&#xD;
        form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading&#xD;
        to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to&#xD;
        improve blood flow.&#xD;
  &#xD;
        However, there are often multiple arteries to treat and each intervention carries risk. It&#xD;
        therefore can be difficult to judge how much treatment is sufficient to promote healing.&#xD;
        Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped&#xD;
        that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve&#xD;
        blood flow, may help in the decision making as to whether further intervention is necessary.&#xD;
        An LSI scan will be performed before a procedure for tissue loss and immediately after it is&#xD;
        performed. The patient's clinical records will then be checked to see whether the wound has&#xD;
        improved and whether the difference in LSI scans correlated with this.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2020</start_date>
    <completion_date type="Actual">January 1, 2021</completion_date>
    <primary_completion_date type="Actual">January 1, 2021</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>fail to heal wounds</measure>
      <time_frame>7 months</time_frame>
      <description>The study aims to assess whether wounds which fail to heal are associated with small differences in LSI blood flow measurements.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">8</enrollment>
    <condition>Vascular Diseases</condition>
    <arm_group>
      <arm_group_label>Patients with diabetes and wound ulcers</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Device to view the skin</intervention_name>
      <description>Application of device to help view the wound area better</description>
      <arm_group_label>Patients with diabetes and wound ulcers</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients with vascular ulcers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with diabetes Patients with a foot ulcer or open wound Patients aged over 18&#xD;
          Patients able to given consent Patients undergoing femoropopliteal bypass or superficial&#xD;
          femoral / popliteal artery angioplasty&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          nability to consent Planned major limb amputation for the affected limb&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Leeds NHS Teaching Hospitals</name>
        <address>
          <city>Leeds</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vascular Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011447
  org study id: VS20/130302
  nct id: NCT06011447
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Peripheral arterial disease is a condition in which the arteries become narrowed due to a
        build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and
        this can compromise the parts of the body supplied by these arteries. In its most severe
        form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading
        to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to
        improve blood flow.
  
        However, there are often multiple arteries to treat and each intervention carries risk. It
        therefore can be difficult to judge how much treatment is sufficient to promote healing.
        Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped
        that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve
        blood flow, may help in the decision making as to whether further intervention is necessary.
        An LSI scan will be performed before a procedure for tissue loss and immediately after it is
        performed. The patient's clinical records will then be checked to see whether the wound has
        improved and whether the difference in LSI scans correlated with this.
  observational model: Cohort
  time perspective: Prospective
  measure: fail to heal wounds
  time frame: 7 months
  description: The study aims to assess whether wounds which fail to heal are associated with small differences in LSI blood flow measurements.
  arm group label: Patients with diabetes and wound ulcers
  intervention type: Other
  intervention name: Device to view the skin
  description: Application of device to help view the wound area better
  arm group label: Patients with diabetes and wound ulcers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Vascular Diseases