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/NCT06007703</url>
    </required_header>
    <id_info>
      <org_study_id>23/006/GHT</org_study_id>
      <secondary_id>327680</secondary_id>
      <nct_id>NCT06007703</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy of Multilayer Compression &amp; UrgoStart Plus</brief_title>
    <official_title>Evaluation of the Safety and Effectiveness of the Global Treatment Including Multilayer Compression Therapy (Urgo KTwo®) in Addition to an Interactive Dressing (UrgoStart® Plus) in the Management of Venous Leg Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gloucestershire Hospitals NHS Foundation Trust</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>
        Historically, venous leg ulcers have been very difficult to manage, with associated poor&#xD;
        healing rates, and the likelihood of recurrence. Even following correction of underlying&#xD;
        venous dysfunction, ulcers can take time to respond to conventional treatment with&#xD;
        compression therapy. Recently, the leg ulcer service in Gloucestershire - part of the&#xD;
        vascular surgical team - have been using an interactive dressing called UrgoStart Plus under&#xD;
        compression therapy in the management of chronic venous leg ulcers and we have experienced&#xD;
        some positive outcomes for otherwise recalcitrant ulcers.&#xD;
  &#xD;
        A previous study published in 2017 by Meaume et al demonstrated a reduction in wound surface&#xD;
        area after 8 weeks of treatment with UrgoStart Plus. However, whether or not use of the&#xD;
        dressing, in combination with compression bandages, improves 12-week healing rates, remains&#xD;
        an unanswered question.&#xD;
  &#xD;
        The aim of the proposed study is to provide an evaluation of this interactive dressing when&#xD;
        used under compression bandages and to compare 12-week healing rates with a similar cohort of&#xD;
        patients who have been treated with a simple low adherent dressing under compression. This&#xD;
        has been our gold standard up to now and we have been collecting prospective data from&#xD;
        patients treated in our unit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Leg ulcers are notoriously difficult to treat with poor outcomes often reported. The majority&#xD;
        of these ulcers are caused by a deficient venous return from the to lower leg and the&#xD;
        mainstay in treatment is compression therapy and further venous treatments such as foam&#xD;
        sclerotherapy. However, some ulcers still take many months to heal causing great suffering&#xD;
        and reduced quality of life and great expense to the NHS.&#xD;
  &#xD;
        More knowledge has been gained concerning the impact of protease (enzyme) activity in venous&#xD;
        leg ulcers and high numbers of these could contribute to the non-healing state. UrgoStart&#xD;
        Plus is an interactive dressing which has a protease modulating effect and has been shown to&#xD;
        reduce proteases and improve healing. The CHALLENGE trial published by Meaume et al (2012)&#xD;
        showed significant reductions in wound surface area following eight weeks of treatment with&#xD;
        UrgoStart for venous leg ulcers and diabetic foot ulcer. However, there is no published data&#xD;
        as yet evaluating impact on healing of venous ulcers at 12 weeks.&#xD;
  &#xD;
        The present study aim is to evaluate the 12-week healing rates in patients with venous leg&#xD;
        ulcers treated in a proven compression system using UrgoStart Plus as the wound contact&#xD;
        layer. This can be compared with 12-week healing for a similar cohort of patients treated&#xD;
        with the same compression system and a simple low adherent non-interactive dressing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Time to healing</measure>
      <time_frame>12 weeks</time_frame>
      <description>Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient health related quality of life</measure>
      <time_frame>12 weeks</time_frame>
      <description>Patient Quality of Life through a specific WoundQuol Questionnaire</description>
    </secondary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Venous Leg Ulcer</condition>
    <condition>Venous Ulcer</condition>
    <condition>Venous Insufficiency of Leg</condition>
    <condition>Leg Ulcer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The patients recruited for this clinical investigation will be patients treated on an&#xD;
          outpatient basis for a venous leg ulcer presenting with an ABPI&gt;0.85 (venous origin). This&#xD;
          is in accordance with local management protocol.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Related to the patient:&#xD;
  &#xD;
            -  Patient over 18 years old who has provided his/her written informed consent,&#xD;
  &#xD;
            -  Patient who is able and willing to commit to regular follow up with the investigating&#xD;
               team for the purpose of the study, and in line with established service protocols for&#xD;
               routine patient follow up until ulcer healed,&#xD;
  &#xD;
            -  Patient who agrees to adhere to the study protocol with respect to the type of&#xD;
               multilayer compression system and primary wound dressing,&#xD;
  &#xD;
          Related to the venous leg ulcer:&#xD;
  &#xD;
            -  Ulcer between 2 and 20 cm² in surface,&#xD;
  &#xD;
            -  Ulcer duration less than six weeks (&quot;new ulcer&quot;),&#xD;
  &#xD;
            -  Venous leg ulcer - Ankle Brachial Pressure Index &gt; 0.85 at baseline, done in the&#xD;
               previous three months and if not, at the inclusion of the patient),&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Related to the patient:&#xD;
  &#xD;
            -  Patient participating in another clinical trial,&#xD;
  &#xD;
            -  Patient with known hypersensitivity to one of the components of the tested compression&#xD;
               system Urgo KTwo Lite Latex free or the UrgoStart dressings,&#xD;
  &#xD;
            -  Patient who is unable to tolerate compression therapy,&#xD;
  &#xD;
            -  Patient presenting a neoplastic lesion treated by radiotherapy or chemotherapy or&#xD;
               patients treated with immunosuppressive drugs or high-dose corticosteroids,&#xD;
  &#xD;
            -  Patient with a history of deep or superficial vein thrombosis in the 3 months prior to&#xD;
               inclusion,&#xD;
  &#xD;
            -  Patient confined to bed.&#xD;
  &#xD;
          Related to the leg ulcer:&#xD;
  &#xD;
            -  Ulcer with ABPI&lt;0.85,&#xD;
  &#xD;
            -  Ulcer which is clinically infected,&#xD;
  &#xD;
            -  Ulcer surface area partially or totally covered by black necrosis plaque,&#xD;
  &#xD;
            -  Malignant ulcer,&#xD;
  &#xD;
            -  Ulcer less than 3 cm, from any edge, to another wound located on the same limb.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Colin E Davies, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gloucestershire Hospitals NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Colin E Davies, MSc</last_name>
      <phone>030042233480</phone>
      <email>colin.davies1@nhs.net</email>
    </overall_contact>
    <reference>
      <citation>Meaume S, Truchetet F, Cambazard F, Lok C, Debure C, Dalac S, Lazareth I, Sigal ML, Sauvadet A, Bohbot S, Dompmartin A; CHALLENGE Study Group. A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers. Wound Repair Regen. 2012 Jul-Aug;20(4):500-11. doi: 10.1111/j.1524-475X.2012.00797.x. Epub 2012 Jun 8.</citation>
      <PMID>22681551</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ulcer</keyword>
    <keyword>Venous</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varicose Ulcer</mesh_term>
      <mesh_term>Venous Insufficiency</mesh_term>
      <mesh_term>Leg Ulcer</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT06007703/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT06007703/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06007703
  org study id: 23/006/GHT
  secondary id: 327680
  nct id: NCT06007703
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Historically, venous leg ulcers have been very difficult to manage, with associated poor
        healing rates, and the likelihood of recurrence. Even following correction of underlying
        venous dysfunction, ulcers can take time to respond to conventional treatment with
        compression therapy. Recently, the leg ulcer service in Gloucestershire - part of the
        vascular surgical team - have been using an interactive dressing called UrgoStart Plus under
        compression therapy in the management of chronic venous leg ulcers and we have experienced
        some positive outcomes for otherwise recalcitrant ulcers.
  
        A previous study published in 2017 by Meaume et al demonstrated a reduction in wound surface
        area after 8 weeks of treatment with UrgoStart Plus. However, whether or not use of the
        dressing, in combination with compression bandages, improves 12-week healing rates, remains
        an unanswered question.
  
        The aim of the proposed study is to provide an evaluation of this interactive dressing when
        used under compression bandages and to compare 12-week healing rates with a similar cohort of
        patients who have been treated with a simple low adherent dressing under compression. This
        has been our gold standard up to now and we have been collecting prospective data from
        patients treated in our unit.
  Leg ulcers are notoriously difficult to treat with poor outcomes often reported. The majority
        of these ulcers are caused by a deficient venous return from the to lower leg and the
        mainstay in treatment is compression therapy and further venous treatments such as foam
        sclerotherapy. However, some ulcers still take many months to heal causing great suffering
        and reduced quality of life and great expense to the NHS.
  
        More knowledge has been gained concerning the impact of protease (enzyme) activity in venous
        leg ulcers and high numbers of these could contribute to the non-healing state. UrgoStart
        Plus is an interactive dressing which has a protease modulating effect and has been shown to
        reduce proteases and improve healing. The CHALLENGE trial published by Meaume et al (2012)
        showed significant reductions in wound surface area following eight weeks of treatment with
        UrgoStart for venous leg ulcers and diabetic foot ulcer. However, there is no published data
        as yet evaluating impact on healing of venous ulcers at 12 weeks.
  
        The present study aim is to evaluate the 12-week healing rates in patients with venous leg
        ulcers treated in a proven compression system using UrgoStart Plus as the wound contact
        layer. This can be compared with 12-week healing for a similar cohort of patients treated
        with the same compression system and a simple low adherent non-interactive dressing.
  observational model: Cohort
  time perspective: Prospective
  measure: Time to healing
  time frame: 12 weeks
  description: Complete ulcer closure (100% re-epithelialisation) after a maximum of 12 weeks treatment period.
  measure: Patient health related quality of life
  time frame: 12 weeks
  description: Patient Quality of Life through a specific WoundQuol Questionnaire
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Colin E Davies, MSc
  role: Principal Investigator
  affiliation: Gloucestershire Hospitals NHS Foundation Trust
  last name: Colin E Davies, MSc
  phone: 030042233480
  email: colin.davies1@nhs.net
  citation: Meaume S, Truchetet F, Cambazard F, Lok C, Debure C, Dalac S, Lazareth I, Sigal ML, Sauvadet A, Bohbot S, Dompmartin A; CHALLENGE Study Group. A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers. Wound Repair Regen. 2012 Jul-Aug;20(4):500-11. doi: 10.1111/j.1524-475X.2012.00797.x. Epub 2012 Jun 8.
  PMID: 22681551
  responsible party type: Sponsor
  mesh term: Varicose Ulcer
  mesh term: Venous Insufficiency
  mesh term: Leg Ulcer
  mesh term: Ulcer
  sharing ipd: No
  provided document: 
  provided document: 