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/NCT06032221</url>
    </required_header>
    <id_info>
      <org_study_id>INGN21DI185</org_study_id>
      <nct_id>NCT06032221</nct_id>
    </id_info>
    <brief_title>Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)</brief_title>
    <official_title>A Feasibility Study Assessing the Impact of At-home Infrared Temperature Monitoring (AITM) With Telemedicine Support in the Management of Patients With Potential for Diabetes Foot Ulceration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NHS Greater Glasgow and Clyde</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Robertson Centre for Biostatistics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NHS Greater Glasgow and Clyde</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 a feasibility study, designed to assess the acceptability of At Home Temperature&#xD;
        Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation&#xD;
        hopes to identify any problems with the study design before progressing to a full-scale&#xD;
        evaluation, and will assess the ease of use of the technology and if there are any barriers&#xD;
        to using this.&#xD;
  &#xD;
        Participants will be provided with an infrared camera and SMART phone and trained in how to&#xD;
        use them. The participants will then be expected to capture images of both the plantar and&#xD;
        dorsal aspects of their feet that will be sent to the research team for review. The two&#xD;
        images will be captured once per day. The Intervention period will be 12 weeks.&#xD;
  &#xD;
        If a raised temperature is identified, the participant will be offered a face to face review&#xD;
        appointment where they will receive podiatry treatment (if required), ulcer prevention advice&#xD;
        and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires&#xD;
        will be used at the start and end of the study period to assess quality of life impact and&#xD;
        device ease of use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 14, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 12, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The purpose of the study is to determine if the Thermidas camera with telemedicine app is a feasible device in the 2 patient cohorts (15 patients who have had previous diabetes foot ulceration and 15 patients who are deemed to be high risk of foot ulceration)</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device Feasibility - Completion</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants successful completion of 12 weeks (percentage of all subjects who were enrolled in the study with ≥70% considered successful target (21 patients). This will assess if usage of the device on a daily basis over a specific period of time is practical</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Withdrawal</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants withdrawal (Percentage of all subjects who were enrolled in the study ≤30% considered successful target). A low withdrawal rate will demonstrate that usage of the device is practical over the time period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Compliance</measure>
      <time_frame>12 weeks</time_frame>
      <description>No submission of images - i.e. no image submissions for 7-consecutive days on 2-occasions, generating 2-alerts over 12 weeks (absolute number of 'no submission' alerts). A lack of compliance with the study protocol will demonstrate low feasibility for regular device usage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Safety</measure>
      <time_frame>12 weeks</time_frame>
      <description>Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument</measure>
      <time_frame>12 weeks</time_frame>
      <description>Patient completion of EQ-5D-5L health utility score to obtain a health utility score at Baseline and at Week 12 (target 80% completion).&#xD;
  (The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), but each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Health Economics</measure>
      <time_frame>12 weeks</time_frame>
      <description>Health care utilisation and costs. The podiatrists will keep a log of time spent checking images and additional appointments generated in response to alerts. Costs will be calculated using staff time x staff payment costs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Staff feedback on device use</measure>
      <time_frame>12 weeks</time_frame>
      <description>A focus group meeting with podiatrists will be scheduled at the end of the participant data collection period to obtain qualitative data relating to device use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Feasibility - Patient feedback on device use</measure>
      <time_frame>12 weeks</time_frame>
      <description>Patient completion of User Questionnaire Form (Week 12) (target 80% completion)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Foot Ulcer, Diabetic</condition>
    <arm_group>
      <arm_group_label>device feasibility</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All participants issued with Thermidas device</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Thermidas Vista Telehealth App</intervention_name>
      <description>Thermal camera with telemedicine app</description>
      <arm_group_label>device feasibility</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Male or Female &gt;/ = 18 years of age&#xD;
  &#xD;
            -  Diabetes Mellitus type 1 or 2 according to WHO criteria&#xD;
  &#xD;
            -  independently ambulatory&#xD;
  &#xD;
            -  deemed high risk/ in remission via SCI diabetes foot risk stratification tool&#xD;
  &#xD;
            -  expected to comply with study schedule&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  active foot ulcer or open amputation site&#xD;
  &#xD;
            -  active Charcot Neuro-osteoarthropathy&#xD;
  &#xD;
            -  active foot infection based on PEDIS classification criteria&#xD;
  &#xD;
            -  amputation proximal to the Chopart joint in one or both feet&#xD;
  &#xD;
            -  critical limb ischaemia (according to PEDIS classification)&#xD;
  &#xD;
            -  severe illness that would make 6-month survival unlikely based on the clinical&#xD;
               judgement of the physician or podiatrist&#xD;
  &#xD;
            -  concomitant severe physical or mental conditions that limit the ability to follow the&#xD;
               instructions of the study, based on the clinical judgement of the physician or&#xD;
               podiatrist&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Queen Elizabeth University Hospital</name>
        <address>
          <city>Glasgow</city>
          <zip>G51 4TF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brian Kennon</last_name>
        <phone>0141 201 1100</phone>
        <email>brian.kennon@ggc.scot.nhs.uk</email>
      </contact>
      <contact_backup>
        <last_name>Ela Fergusson</last_name>
        <phone>0141 451 6869</phone>
        <email>pamela.fergusson3@ggc.scot.nhs.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Gillian Harkin</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Diabetic Foot</mesh_term>
      <mesh_term>Foot Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06032221
  org study id: INGN21DI185
  nct id: NCT06032221
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a feasibility study, designed to assess the acceptability of At Home Temperature
        Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation
        hopes to identify any problems with the study design before progressing to a full-scale
        evaluation, and will assess the ease of use of the technology and if there are any barriers
        to using this.
  
        Participants will be provided with an infrared camera and SMART phone and trained in how to
        use them. The participants will then be expected to capture images of both the plantar and
        dorsal aspects of their feet that will be sent to the research team for review. The two
        images will be captured once per day. The Intervention period will be 12 weeks.
  
        If a raised temperature is identified, the participant will be offered a face to face review
        appointment where they will receive podiatry treatment (if required), ulcer prevention advice
        and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires
        will be used at the start and end of the study period to assess quality of life impact and
        device ease of use.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The purpose of the study is to determine if the Thermidas camera with telemedicine app is a feasible device in the 2 patient cohorts (15 patients who have had previous diabetes foot ulceration and 15 patients who are deemed to be high risk of foot ulceration)
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Device Feasibility - Completion
  time frame: 12 weeks
  description: Participants successful completion of 12 weeks (percentage of all subjects who were enrolled in the study with ≥70% considered successful target (21 patients). This will assess if usage of the device on a daily basis over a specific period of time is practical
  measure: Device Feasibility - Withdrawal
  time frame: 12 weeks
  description: Participants withdrawal (Percentage of all subjects who were enrolled in the study ≤30% considered successful target). A low withdrawal rate will demonstrate that usage of the device is practical over the time period
  measure: Device Feasibility - Compliance
  time frame: 12 weeks
  description: No submission of images - i.e. no image submissions for 7-consecutive days on 2-occasions, generating 2-alerts over 12 weeks (absolute number of 'no submission' alerts). A lack of compliance with the study protocol will demonstrate low feasibility for regular device usage
  measure: Device Feasibility - Safety
  time frame: 12 weeks
  description: Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
  measure: Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
  time frame: 12 weeks
  description: Patient completion of EQ-5D-5L health utility score to obtain a health utility score at Baseline and at Week 12 (target 80% completion).
  (The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), but each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each)
  measure: Device Feasibility - Health Economics
  time frame: 12 weeks
  description: Health care utilisation and costs. The podiatrists will keep a log of time spent checking images and additional appointments generated in response to alerts. Costs will be calculated using staff time x staff payment costs
  measure: Device Feasibility - Staff feedback on device use
  time frame: 12 weeks
  description: A focus group meeting with podiatrists will be scheduled at the end of the participant data collection period to obtain qualitative data relating to device use.
  measure: Device Feasibility - Patient feedback on device use
  time frame: 12 weeks
  description: Patient completion of User Questionnaire Form (Week 12) (target 80% completion)
  arm group label: device feasibility
  arm group type: Other
  description: All participants issued with Thermidas device
  intervention type: Device
  intervention name: Thermidas Vista Telehealth App
  description: Thermal camera with telemedicine app
  arm group label: device feasibility
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  sharing ipd: No