<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/NCT02967900</url>
  </required_header>
  <id_info>
    <org_study_id>1200</org_study_id>
    <nct_id>NCT02967900</nct_id>
  </id_info>
  <brief_title>Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies</brief_title>
  <official_title>Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michelson Diagnostics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Michelson Diagnostics Ltd.</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>
      An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised&#xD;
      treatment, over a 16 week period conducted at out-patient level, utilising novel optical&#xD;
      wound measurement technologies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic foot ulcers are a major burden on the healthcare system, and it is highly desirable&#xD;
      to develop a practical, reliable, non-invasive means of diagnosing, assessing and measuring&#xD;
      wound healing, so as to provide wound care specialists with key data with which to make&#xD;
      effective decisions for clinical management.&#xD;
&#xD;
      Optical coherence tomography (OCT) is a novel technique of imaging of cutaneous tissue. Using&#xD;
      low-power infrared light, it is a non-invasive in-vivo imaging technique which provides&#xD;
      resolution of &lt;10microns to a depth of 1 - 1.25 mm in skin, (adequate to resolve capillaries)&#xD;
      utilizing the optical scattering characteristics of tissue to provide imaging contrast.&#xD;
&#xD;
      This open, non-randomised, observational study will assess the feasibility of using OCT to&#xD;
      diagnose chronic diabetic foot ulcers. One cohort of 15 patients will be scanned over a 16&#xD;
      week period and results studied to determine whether there is an association between rate of&#xD;
      wound healing and OCT measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of OCT Measurement of blood vessel density with rate of wound healing</measure>
    <time_frame>16 weeks</time_frame>
    <description>Pearson's coefficient of correlation between the OCT measurement of blood vessel density (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow) and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound per 4 week period), as an average across all trial subjects and all measurement points during the trial.&#xD;
Pearson's coefficient &gt; 50% signifies a positive result.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing</measure>
    <time_frame>16 weeks</time_frame>
    <description>Pearson's coefficient of correlation between the OCT measurement of blood vessel density at baseline, (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow), and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound over the 16 week trial period), as an average across all trial subjects.&#xD;
Pearson's coefficient &gt; 50% signifies a positive result.</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      2 mm punch biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending hospital outpatient, day care or inpatient clinic, &gt; 18 years and&#xD;
        capable of giving informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Defining ABPI ≥0.5 - &lt;1.2&#xD;
&#xD;
          -  Patients with DFU for over 4 weeks but less than 1 year duration. DFU resulting from&#xD;
             neuropathy will be included.&#xD;
&#xD;
          -  Neuropathy scores defined by 10g Semmes-Weinstein monofilament tests at 10 sites on&#xD;
             plantar and dorsal surfaces&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled diabetes, the Charcot Foot, cancer (except non-melanoma&#xD;
             skin cancer in the limb), decompensated cardiac failure, clinically significant renal&#xD;
             failure, history of stroke or significant peripheral arterial disease, or those who&#xD;
             are pregnant, or on a waiting list for interventional therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank L Bowling, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Manchester University Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>August 31, 2018</last_update_submitted>
  <last_update_submitted_qc>August 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 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>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>


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/NCT02967900
org study id: 1200
nct id: NCT02967900
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised
      treatment, over a 16 week period conducted at out-patient level, utilising novel optical
      wound measurement technologies.
Diabetic foot ulcers are a major burden on the healthcare system, and it is highly desirable
      to develop a practical, reliable, non-invasive means of diagnosing, assessing and measuring
      wound healing, so as to provide wound care specialists with key data with which to make
      effective decisions for clinical management.

      Optical coherence tomography (OCT) is a novel technique of imaging of cutaneous tissue. Using
      low-power infrared light, it is a non-invasive in-vivo imaging technique which provides
      resolution of <10microns to a depth of 1 - 1.25 mm in skin, (adequate to resolve capillaries)
      utilizing the optical scattering characteristics of tissue to provide imaging contrast.

      This open, non-randomised, observational study will assess the feasibility of using OCT to
      diagnose chronic diabetic foot ulcers. One cohort of 15 patients will be scanned over a 16
      week period and results studied to determine whether there is an association between rate of
      wound healing and OCT measurements.
observational model: Cohort
time perspective: Retrospective
measure: Correlation of OCT Measurement of blood vessel density with rate of wound healing
time frame: 16 weeks
description: Pearson's coefficient of correlation between the OCT measurement of blood vessel density (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow) and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound per 4 week period), as an average across all trial subjects and all measurement points during the trial.
Pearson's coefficient > 50% signifies a positive result.
measure: Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing
time frame: 16 weeks
description: Pearson's coefficient of correlation between the OCT measurement of blood vessel density at baseline, (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow), and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound over the 16 week trial period), as an average across all trial subjects.
Pearson's coefficient > 50% signifies a positive result.
2 mm punch biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Frank L Bowling, PhD
role: Principal Investigator
affiliation: Central Manchester University Hospital NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No