<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/NCT03270904</url>
  </required_header>
  <id_info>
    <org_study_id>VS17/99990</org_study_id>
    <nct_id>NCT03270904</nct_id>
  </id_info>
  <brief_title>Moleculight i:X™ in Wound Healing</brief_title>
  <official_title>The Use of Moleculight i:X™ in the Management of Diabetic Foot Ulcers: A Pilot Study</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>
      Diabetic foot disease is a global health problem. Diabetes affects over 450million people&#xD;
      worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their&#xD;
      feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than&#xD;
      half of DFUs become infected requiring hospitalisation and 20% of infections result in&#xD;
      amputations contributing to 80% of non-traumatic amputations performed in the developed&#xD;
      world. DFUs cost the NHS £1billion in financial year 2014-15.&#xD;
&#xD;
      A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to&#xD;
      progress through the normal phases of wound healing in an orderly and timely manner and&#xD;
      become hard to heal. Almost all chronic wounds are known to have bacteria within and this is&#xD;
      termed colonisation. Wounds can progress from being colonised to becoming infected. The&#xD;
      concentration of bacteria can predict delayed healing or infection.&#xD;
&#xD;
      This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to&#xD;
      investigate the clinical effectiveness and decision making associated with its use in the&#xD;
      assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By&#xD;
      controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria&#xD;
      above a pre-determined concentration by identifying natural fluorescence in the bacteria cell&#xD;
      wall.&#xD;
&#xD;
      Patients attending a specialist DFU clinic will be screened and if eligible and consenting&#xD;
      will be recruited. Patients will be randomised into two groups; those who receive treatments&#xD;
      as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus&#xD;
      Moleculight i:X™ imaging. The main objective is to describe the proportion per group with&#xD;
      healed DFUs at 12week follow up in these two comparable groups of 30 patients each.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of diabetic foot ulcers healed at 12 weeks post randomisation</measure>
    <time_frame>12 weeks</time_frame>
    <description>The proportion of diabetic foot ulcers which have healed in both group 1 and group 2 at 12 weeks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ulcer Foot</condition>
  <arm_group>
    <arm_group_label>Group 1 - Interventional Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group have been randomised to receive application of violet blue light administered by the hand held Microlight i:X device in addition to routine care of their foot ulcer. This intervention will be administered four times during the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group receive routine care and no additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Moleculight i:X™ fluorescence imaging</intervention_name>
    <description>Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.</description>
    <arm_group_label>Group 1 - Interventional Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 18 years&#xD;
&#xD;
          2. Diagnosis of Diabetes (according to WHO criteria)&#xD;
&#xD;
          3. Has ulceration of the foot below the malleoli&#xD;
&#xD;
          4. Expected to comply with the treatment strategies and follow up schedule&#xD;
&#xD;
          5. Consent to foot and wound photography&#xD;
&#xD;
          6. Consent to participate (written/witnessed verbal consent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).&#xD;
&#xD;
          2. Estimated glomerular filtration rate (eGFR) &lt;20mL/min/1.73m2 (measurements taken&#xD;
             within 3 months of randomisation can be used if no change in intervention or vascular&#xD;
             events have occurred)&#xD;
&#xD;
          3. Has ABPI &lt;0.5 or opening toe pressure &lt;30mmHg (measured within 3 months of&#xD;
             randomisation)&#xD;
&#xD;
          4. Planned or previous treatment with corticosteroids to an equivalent dose of&#xD;
             Prednisolone &gt;10mg per day or other immunosuppressive therapy within 4 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          5. Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis)&#xD;
             and has planned or is under active treatment.&#xD;
&#xD;
          6. Has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis&#xD;
             bullosa)&#xD;
&#xD;
          7. Has previously been randomised to the Moleculight i:X™ study&#xD;
&#xD;
          8. Lacks mental capacity and is unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Russell, MB ChB, MD</last_name>
    <phone>+44 113 243 2799</phone>
    <email>davidrussell1@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</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>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>


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/NCT03270904
org study id: VS17/99990
nct id: NCT03270904
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Diabetic foot disease is a global health problem. Diabetes affects over 450million people
      worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their
      feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than
      half of DFUs become infected requiring hospitalisation and 20% of infections result in
      amputations contributing to 80% of non-traumatic amputations performed in the developed
      world. DFUs cost the NHS £1billion in financial year 2014-15.

      A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to
      progress through the normal phases of wound healing in an orderly and timely manner and
      become hard to heal. Almost all chronic wounds are known to have bacteria within and this is
      termed colonisation. Wounds can progress from being colonised to becoming infected. The
      concentration of bacteria can predict delayed healing or infection.

      This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to
      investigate the clinical effectiveness and decision making associated with its use in the
      assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By
      controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria
      above a pre-determined concentration by identifying natural fluorescence in the bacteria cell
      wall.

      Patients attending a specialist DFU clinic will be screened and if eligible and consenting
      will be recruited. Patients will be randomised into two groups; those who receive treatments
      as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus
      Moleculight i:X™ imaging. The main objective is to describe the proportion per group with
      healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of diabetic foot ulcers healed at 12 weeks post randomisation
time frame: 12 weeks
description: The proportion of diabetic foot ulcers which have healed in both group 1 and group 2 at 12 weeks.
arm group label: Group 1 - Interventional Treatment
arm group type: Experimental
description: Participants in this group have been randomised to receive application of violet blue light administered by the hand held Microlight i:X device in addition to routine care of their foot ulcer. This intervention will be administered four times during the study.
arm group label: Group 2 - Usual care
arm group type: No Intervention
description: This group receive routine care and no additional intervention.
intervention type: Device
intervention name: Moleculight i:X™ fluorescence imaging
description: Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
arm group label: Group 1 - Interventional Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: David Russell, MB ChB, MD
phone: +44 113 243 2799
email: davidrussell1@nhs.net
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Foot Ulcer
sharing ipd: No