<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/NCT03002116</url>
  </required_header>
  <id_info>
    <org_study_id>EBΔ 1310/10-2-16</org_study_id>
    <nct_id>NCT03002116</nct_id>
  </id_info>
  <brief_title>Microwave Radiometry Thermometry for the Diagnosis of Critical Limb Ischemia in Diabetic Patients</brief_title>
  <official_title>Microwave Radiometry Thermometry for Non-invasive Diagnosis of Arterial Disease in Diabetic Patients With Suspected Critical Limb Ischemia: A Multi-centre Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of Patras</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bolton Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential&#xD;
      diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of&#xD;
      clinical examination, medical history and ankle-brachial index (ABI) measurement, which is&#xD;
      considered the &quot;gold standard&quot; non-invasive modality for limb ischemia diagnosis. However, in&#xD;
      diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb&#xD;
      ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis&#xD;
      producing incompressible vessels, while clinical signs are subjective and not accurate in&#xD;
      posing definite diagnosis of CLI.&#xD;
&#xD;
      The investigators conducted a proof of concept study of the feasibility of microwave&#xD;
      radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue&#xD;
      loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-centre, trial designed to investigate the he feasibility and&#xD;
      efficacy of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic&#xD;
      patients with tissue loss. The study included 80 patients, equally divided in four groups.&#xD;
      Group N: normal subjects; group DN: diabetic patients with verified neuropathic ulcers&#xD;
      without vascular involvement; group DC: diabetic patients with CLI and group NDC:&#xD;
      non-diabetic patients with CLI. All patients underwent MWR with the RTM -01-RES device&#xD;
      (University of Bolton, UK) to record the mean internal tissue temperature of the foot. MWR is&#xD;
      based on the principle that the intensity of radiation is proportional to tissue temperature.&#xD;
      The specific device is not commercially available and has been developed to detect&#xD;
      temperatures from internal tissues at microwave frequencies. Foot temperature measurements&#xD;
      were performed as near as possible at the site of ulceration in patients of groups DN, DC and&#xD;
      NDC and in various sites in subjects of control group N.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean foot tissue temperature</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Diabetic Foot</condition>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Ischaemic Neuropathy</condition>
  <arm_group>
    <arm_group_label>Group N</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy volunteers without peripheral arterial disease according to clinical examination and Duplex ultrasound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group DN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from diabetes and diabetic foot without vascular compromise according to clinical assessment continuous-wave Doppler and Duplex ultrasound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group DC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group NDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tissue thermometry using non-invasive microwave radiometry device</intervention_name>
    <description>In Patients included in the four study groups underwent non-invasive tissue thermometry using microwave radiometry (MWR) device, at the same room temperature and with the same methodology. Specifically, the probe of the RTM-01-RES (University of Bolton, UK) device was by applied on the surface of the foot tissue at an angle of 90o degrees for approximately 8 to 10 seconds in pre-determined sites. Measurements were performed by two independent operators. Three measurements were taken from each site. The mean value of the three values calculated by the 2 different operators was used for the analysis. Measurements were recorded using a dedicated software.</description>
    <arm_group_label>Group DC</arm_group_label>
    <arm_group_label>Group DN</arm_group_label>
    <arm_group_label>Group N</arm_group_label>
    <arm_group_label>Group NDC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from both insulin and not insulin dependent diabetes mellitus.&#xD;
&#xD;
          -  Critical limb ischemia verified by both clinical examination, haemodynamic tests and&#xD;
             digital subtraction angiography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncertainty regarding the absence of peripheral arterial disease in groups N and DN.&#xD;
&#xD;
          -  Uncertainty regarding the diagnosis of critical limb ischemia for patients in groups&#xD;
             DC and NDC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elias Brountzos, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>ATTIKO University General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patras University Hospital</name>
      <address>
        <city>Rio</city>
        <state>Achaia</state>
        <zip>26500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Attiko University General Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>12461</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Materials Research and Innovation, University of Bolton</name>
      <address>
        <city>Bolton</city>
        <zip>BL3 5AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 14, 2020</last_update_submitted>
  <last_update_submitted_qc>April 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Stavros Spiliopoulos</investigator_full_name>
    <investigator_title>Assistant Professor of Radiology.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03002116
org study id: EBΔ 1310/10-2-16
nct id: NCT03002116
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Diagnosis of vascular involvement in diabetic foot disease remains challenging. Differential
      diagnosis between pure neuropathic or neuro-ischemic diabetic foot requires a combination of
      clinical examination, medical history and ankle-brachial index (ABI) measurement, which is
      considered the "gold standard" non-invasive modality for limb ischemia diagnosis. However, in
      diabetic patients with suspected arterial ischemia resulting in tissue loss (critical limb
      ischemia; CLI), false negative ABI results are frequent due to Monckeberg medial sclerosis
      producing incompressible vessels, while clinical signs are subjective and not accurate in
      posing definite diagnosis of CLI.

      The investigators conducted a proof of concept study of the feasibility of microwave
      radiometry thermometry for non-invasive diagnosis of CLI in diabetic patients with tissue
      loss.
This is a prospective, multi-centre, trial designed to investigate the he feasibility and
      efficacy of microwave radiometry thermometry for non-invasive diagnosis of CLI in diabetic
      patients with tissue loss. The study included 80 patients, equally divided in four groups.
      Group N: normal subjects; group DN: diabetic patients with verified neuropathic ulcers
      without vascular involvement; group DC: diabetic patients with CLI and group NDC:
      non-diabetic patients with CLI. All patients underwent MWR with the RTM -01-RES device
      (University of Bolton, UK) to record the mean internal tissue temperature of the foot. MWR is
      based on the principle that the intensity of radiation is proportional to tissue temperature.
      The specific device is not commercially available and has been developed to detect
      temperatures from internal tissues at microwave frequencies. Foot temperature measurements
      were performed as near as possible at the site of ulceration in patients of groups DN, DC and
      NDC and in various sites in subjects of control group N.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean foot tissue temperature
time frame: 15 minutes
arm group label: Group N
arm group type: Active Comparator
description: Healthy volunteers without peripheral arterial disease according to clinical examination and Duplex ultrasound
arm group label: Group DN
arm group type: Experimental
description: Patients suffering from diabetes and diabetic foot without vascular compromise according to clinical assessment continuous-wave Doppler and Duplex ultrasound
arm group label: Group DC
arm group type: Experimental
description: Diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.
arm group label: Group NDC
arm group type: Experimental
description: Non diabetic patients with Rutherford-Becker 5 or 6 critical limb ischemia, verified by clinical examination, abnormal continuous-wave Doppler or Duplex ultrasound and intra-arterial angiography.
intervention type: Other
intervention name: Tissue thermometry using non-invasive microwave radiometry device
description: In Patients included in the four study groups underwent non-invasive tissue thermometry using microwave radiometry (MWR) device, at the same room temperature and with the same methodology. Specifically, the probe of the RTM-01-RES (University of Bolton, UK) device was by applied on the surface of the foot tissue at an angle of 90o degrees for approximately 8 to 10 seconds in pre-determined sites. Measurements were performed by two independent operators. Three measurements were taken from each site. The mean value of the three values calculated by the 2 different operators was used for the analysis. Measurements were recorded using a dedicated software.
arm group label: Group DC
arm group label: Group DN
arm group label: Group N
arm group label: Group NDC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elias Brountzos, MD, PhD
role: Study Chair
affiliation: ATTIKO University General Hospital
facility: 
facility: 
facility: 
country: Greece
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Stavros Spiliopoulos
investigator title: Assistant Professor of Radiology.
mesh term: Diabetic Foot
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: Undecided