<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/NCT02224742</url>
  </required_header>
  <id_info>
    <org_study_id>12EN005</org_study_id>
    <secondary_id>ISRCTN27665670</secondary_id>
    <nct_id>NCT02224742</nct_id>
  </id_info>
  <brief_title>LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers</brief_title>
  <official_title>LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic foot ulcers are the source of considerable suffering and cost and there are&#xD;
      currently no wound care products available that have been demonstrated to improve healing, or&#xD;
      that are cost effective. There have however been a small number of studies which have&#xD;
      examined the use of platelets or fluid derived from platelets, either from the patient's own&#xD;
      blood or from blood bank products. These have suggested some promise, but have suffered from&#xD;
      technical difficulties in making a suitable wound care product or the volume of blood&#xD;
      required to derive the product. It is thought that the reason why they may work is that&#xD;
      growth factors released by the platelets may stimulate the wound to heal.&#xD;
&#xD;
      This study will be a formal, randomised controlled trial to assess a new device for creating&#xD;
      a wound care product which is a plug or patch comprising fibrin, white cells and platelets&#xD;
      derived from 18 mls of the patients own blood. The application of this fibrin/white&#xD;
      cell/platelet patch to the patients wound on a weekly basis will be compared with usual best&#xD;
      care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25&#xD;
      centres in the United Kingdom, Denmark and Sweden.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healing</measure>
    <time_frame>Within 20 weeks of randomisation</time_frame>
    <description>Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">269</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>LeucoPatch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual care supplemented by the application of LeucoPatch centrifugates that comprise autologous fibrin patches containing living white cells and platelets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care provided in a multidisciplinary foot care clinic, in accordance with international guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LeucoPatch</intervention_name>
    <description>LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.</description>
    <arm_group_label>LeucoPatch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines.&#xD;
Components of usual wound care include:&#xD;
Formal assessment of ulcer and surrounding skin&#xD;
Provision of any necessary off-loading&#xD;
Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae)&#xD;
Appropriate dressing products&#xD;
Appropriate antibiotic therapy&#xD;
Nutrition and self care&#xD;
Optimal glycaemic control&#xD;
Revascularisation if deemed clinically necessary&#xD;
Continued close observation</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People aged 18 years and over who have diabetes complicated by one or more ulcers on a&#xD;
             foot or both feet below the level of the malleoli, excluding ulcers confined to the&#xD;
             interdigital cleft.&#xD;
&#xD;
          -  Those with more than one eligible ulcer will have one - usually the largest or more&#xD;
             clinically significant - selected at screening as the index ulcer.&#xD;
&#xD;
          -  Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will&#xD;
             decrease by less than 50 % during a four week run-in period.&#xD;
&#xD;
          -  The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of&#xD;
             the 4 week run-in period.&#xD;
&#xD;
          -  At randomisation, the index ulcer will be clinically non-infected according to IDSA&#xD;
             criteria&#xD;
&#xD;
          -  Either the ankle-brachial index (ABPI) in the affected limb will be between 0.50 and&#xD;
             1.40 or the dorsalis pedis pulse and/or tibialis posterior pulse will be palpable.&#xD;
&#xD;
          -  HbA1c ≤108 mmol/mol at screening&#xD;
&#xD;
          -  Participants will have the capacity to understand study procedures, and will be able&#xD;
             to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Haemoglobin concentration &lt;105 g/L or 6.5 mmol/L at screening.&#xD;
&#xD;
          -  Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (&lt;100x109/L) or other&#xD;
             clinically significant blood dyscrasia&#xD;
&#xD;
          -  Known potential infectivity of blood products, including known HIV and hepatitis&#xD;
&#xD;
          -  Dialysis or an estimated GFR (based on cystatine C or serum creatinine) &lt;20&#xD;
             ml/min/1.73m2&#xD;
&#xD;
          -  Increase in cross-sectional area of the index ulcer by ≥25% during the 4 week run-in&#xD;
             period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that&#xD;
             time.&#xD;
&#xD;
          -  Clinical signs of infection of the index ulcer or reason to suspect that infection is&#xD;
             present at randomisation.&#xD;
&#xD;
          -  Revascularisation procedure in the affected limb planned, or undertaken within the&#xD;
             preceding 4 weeks.&#xD;
&#xD;
          -  Current treatment with cytotoxic drugs or with systemically administered&#xD;
             glucocorticoids or other immunosuppressants.&#xD;
&#xD;
          -  Treatment of foot ulcers with growth factors, stem cells or equivalent preparation&#xD;
             within the preceding 8 weeks&#xD;
&#xD;
          -  The need for continued use of negative pressure wound therapy&#xD;
&#xD;
          -  Likely inability to comply with the need for weekly visits because of planned&#xD;
             activity.&#xD;
&#xD;
          -  Participation in another interventional clinical foot ulcer-healing trial within last&#xD;
             the 4 weeks at the time of screening.&#xD;
&#xD;
          -  Prior randomisation in this trial.&#xD;
&#xD;
          -  Judgement by the investigator that the patient does not have the capacity to&#xD;
             understand the study procedures or provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances Game, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals of Derby and Burton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Steno Diabetes Center</name>
      <address>
        <city>Gentofte</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjællands Hospital</name>
      <address>
        <city>Hillerød</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Kobenhavn NV</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolding Sygehus</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viborg Sårcenter</name>
      <address>
        <city>Viborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralsjukhuset Kristianstad</name>
      <address>
        <city>Kristianstad</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skåne University Hospital</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Solna</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TRI 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Devon Healthcare NHS Foundation Trust</name>
      <address>
        <city>Torquay</city>
        <state>Devon</state>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ipswich Hospital NHS Trust</name>
      <address>
        <city>Ipswich</city>
        <state>Suffolk</state>
        <zip>IP4 5PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mid Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Pontefract</city>
        <state>West Yorkshire</state>
        <zip>WF8 1PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Foundation Trust</name>
      <address>
        <city>Barnsley</city>
        <zip>S75 2EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancashire Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Chorley</city>
        <zip>PR7 1PP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartford and Gravesham NHS Trust</name>
      <address>
        <city>Dartford</city>
        <zip>DA2 8DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derby Hospitals NHS Foundation Trust</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dudley Group NHS Foundation Trust</name>
      <address>
        <city>Dudley</city>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gateshead Health NHS Foundation Trust</name>
      <address>
        <city>Gateshead</city>
        <zip>NE9 6SX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrogate and District NHS Foundation Trust</name>
      <address>
        <city>Harrogate</city>
        <zip>HG2 7SX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Leicester NHSTrust</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals NHS Trust</name>
      <address>
        <city>Lincoln</city>
        <zip>LN2 5QY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwich and Norwich University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5BS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospitals Sunderland NHS Foundation Trust</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Wolverhampton Hospitals NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT02224742
org study id: 12EN005
secondary id: ISRCTN27665670
nct id: NCT02224742
lead sponsor: 
has dmc: No
Diabetic foot ulcers are the source of considerable suffering and cost and there are
      currently no wound care products available that have been demonstrated to improve healing, or
      that are cost effective. There have however been a small number of studies which have
      examined the use of platelets or fluid derived from platelets, either from the patient's own
      blood or from blood bank products. These have suggested some promise, but have suffered from
      technical difficulties in making a suitable wound care product or the volume of blood
      required to derive the product. It is thought that the reason why they may work is that
      growth factors released by the platelets may stimulate the wound to heal.

      This study will be a formal, randomised controlled trial to assess a new device for creating
      a wound care product which is a plug or patch comprising fibrin, white cells and platelets
      derived from 18 mls of the patients own blood. The application of this fibrin/white
      cell/platelet patch to the patients wound on a weekly basis will be compared with usual best
      care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25
      centres in the United Kingdom, Denmark and Sweden.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Healing
time frame: Within 20 weeks of randomisation
description: Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group.
arm group label: LeucoPatch
arm group type: Experimental
description: Usual care supplemented by the application of LeucoPatch centrifugates that comprise autologous fibrin patches containing living white cells and platelets
arm group label: Usual care
arm group type: Active Comparator
description: Usual care provided in a multidisciplinary foot care clinic, in accordance with international guidelines
intervention type: Device
intervention name: LeucoPatch
description: LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.
arm group label: LeucoPatch
intervention type: Other
intervention name: Usual care
description: Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines.
Components of usual wound care include:
Formal assessment of ulcer and surrounding skin
Provision of any necessary off-loading
Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae)
Appropriate dressing products
Appropriate antibiotic therapy
Nutrition and self care
Optimal glycaemic control
Revascularisation if deemed clinically necessary
Continued close observation
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frances Game, FRCP
role: Principal Investigator
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
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country: Denmark
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer