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/NCT06000722</url>
    </required_header>
    <id_info>
      <org_study_id>40318</org_study_id>
      <nct_id>NCT06000722</nct_id>
    </id_info>
    <brief_title>SGLT2-I Use in DFUD: a Delphi Study</brief_title>
    <official_title>The Generation of Expert Consensus-based Clinical Guidelines for the Use of Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors in Patients With Diabetic Foot Ulcer Disease: a Delphi Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Leicester</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>
        Background: People with diabetes and either current or previous diabetic foot ulcer disease&#xD;
        (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and&#xD;
        strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that&#xD;
        have shown to be very effective in reducing heart disease and event risk. However, one recent&#xD;
        study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this&#xD;
        finding has not been replicated in other similar studies. However, as a result, there has&#xD;
        been limited further investigation into this issue and as such the use of SGLT2i's in those&#xD;
        with DFUD remains a contentious issue, despite their potential for significantly reducing&#xD;
        cardiovascular disease risk in this population.&#xD;
  &#xD;
        In the absence of further randomised controlled trials investigating the use of SGLT2is in&#xD;
        these populations, there is a need for clinical guidelines advising on their use based on&#xD;
        expert clinical consensus, including specific criteria or scenarios in which they should or&#xD;
        should not be used. The Delphi methodology is an iterative survey technique that uses expert&#xD;
        opinion from various relevant backgrounds and experiences to generate a consensus based upon&#xD;
        various statements and/or scenarios.&#xD;
  &#xD;
        Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based&#xD;
        clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD.&#xD;
  &#xD;
        Methods: This is a Delphi technique-based study using a purposive sample of convenience.&#xD;
        Consensus development methods will be used to generate clinical guidelines, endorsed by key&#xD;
        clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease,&#xD;
        including acknowledgement of specific scenarios or patient characteristics that may influence&#xD;
        these guidelines.&#xD;
  &#xD;
        The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary&#xD;
        care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure&#xD;
        a breadth of expertise and input. Two rounds of the Delphi consensus process will take place,&#xD;
        in order to iteratively develop the consensus-based clinical guidelines. This process is&#xD;
        expected to take 4-6 months. The analysis will be on-going throughout the study and completed&#xD;
        within 3 months of the last questionnaire round of the Delphi process.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Delphi Round 1</measure>
      <time_frame>3 weeks</time_frame>
      <description>Each participant will provided with the clinical statements regarding the use of SGLT2i's in patients with diabetic foot ulcer disease, and sent the link to an online questionnaire. Within the first questionnaire round the participants will be asked to rate these statements i.e. strongly agree, agree, uncertain (probably agree), uncertain (probably disagree), disagree, strongly disagree. Participants will be given three weeks to complete this questionnaire, and will be sent reminder emails during this time. This will establish priorities amongst the statements listed. As a result of completing round one, areas of disagreement and agreement will be identified and a level of consensus will begin to form.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Delphi Round 2</measure>
      <time_frame>3 weeks</time_frame>
      <description>The second round of the questionnaire will consist of a summary of the items and ratings from the previous round. Participants will be asked to revise his/her judgments or to specify why they wish to remain outside of the consensus. This round gives the Delphi participants an opportunity to make further clarifications of both the information &amp; their judgment of the relative importance of the items. Round 2 will be initiated 1 month after the completion of round 1. If consensus is not reached on the majority of statements following round 2, and third and final round may be added in order to reach consensus.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Healthcare practitioners</arm_group_label>
      <description>Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>eDelphi method</intervention_name>
      <description>This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.</description>
      <arm_group_label>Healthcare practitioners</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants in the Delphi study will consist of n=20 healthcare practitioners based across&#xD;
          the United Kingdom and will be recruited from a convenience sample geographically spread in&#xD;
          England, and representing a range of specialties and clinical backgrounds.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who are trained healthcare practitioners involved in the care of patients&#xD;
               with current or previous diabetic foot ulcer disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Potential participants who do not give informed consent. Potential participants who&#xD;
               will not be able to participate in both rounds of the Delphi process.&#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>
    <overall_contact>
      <last_name>Patrick Highton, PhD</last_name>
      <phone>07964523232</phone>
      <email>ph204@leicester.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kamlesh Khunti, FMedSci</last_name>
      <email>kk22@leicester.ac.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>
    <!-- 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/NCT06000722
  org study id: 40318
  nct id: NCT06000722
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: People with diabetes and either current or previous diabetic foot ulcer disease
        (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and
        strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that
        have shown to be very effective in reducing heart disease and event risk. However, one recent
        study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this
        finding has not been replicated in other similar studies. However, as a result, there has
        been limited further investigation into this issue and as such the use of SGLT2i's in those
        with DFUD remains a contentious issue, despite their potential for significantly reducing
        cardiovascular disease risk in this population.
  
        In the absence of further randomised controlled trials investigating the use of SGLT2is in
        these populations, there is a need for clinical guidelines advising on their use based on
        expert clinical consensus, including specific criteria or scenarios in which they should or
        should not be used. The Delphi methodology is an iterative survey technique that uses expert
        opinion from various relevant backgrounds and experiences to generate a consensus based upon
        various statements and/or scenarios.
  
        Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based
        clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD.
  
        Methods: This is a Delphi technique-based study using a purposive sample of convenience.
        Consensus development methods will be used to generate clinical guidelines, endorsed by key
        clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease,
        including acknowledgement of specific scenarios or patient characteristics that may influence
        these guidelines.
  
        The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary
        care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure
        a breadth of expertise and input. Two rounds of the Delphi consensus process will take place,
        in order to iteratively develop the consensus-based clinical guidelines. This process is
        expected to take 4-6 months. The analysis will be on-going throughout the study and completed
        within 3 months of the last questionnaire round of the Delphi process.
  observational model: Other
  time perspective: Prospective
  measure: Delphi Round 1
  time frame: 3 weeks
  description: Each participant will provided with the clinical statements regarding the use of SGLT2i's in patients with diabetic foot ulcer disease, and sent the link to an online questionnaire. Within the first questionnaire round the participants will be asked to rate these statements i.e. strongly agree, agree, uncertain (probably agree), uncertain (probably disagree), disagree, strongly disagree. Participants will be given three weeks to complete this questionnaire, and will be sent reminder emails during this time. This will establish priorities amongst the statements listed. As a result of completing round one, areas of disagreement and agreement will be identified and a level of consensus will begin to form.
  measure: Delphi Round 2
  time frame: 3 weeks
  description: The second round of the questionnaire will consist of a summary of the items and ratings from the previous round. Participants will be asked to revise his/her judgments or to specify why they wish to remain outside of the consensus. This round gives the Delphi participants an opportunity to make further clarifications of both the information & their judgment of the relative importance of the items. Round 2 will be initiated 1 month after the completion of round 1. If consensus is not reached on the majority of statements following round 2, and third and final round may be added in order to reach consensus.
  arm group label: Healthcare practitioners
  description: Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease
  intervention type: Other
  intervention name: eDelphi method
  description: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.
  arm group label: Healthcare practitioners
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Patrick Highton, PhD
  phone: 07964523232
  email: ph204@leicester.ac.uk
  last name: Kamlesh Khunti, FMedSci
  email: kk22@leicester.ac.uk
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer