<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/NCT03275831</url>
  </required_header>
  <id_info>
    <org_study_id>R17-006</org_study_id>
    <secondary_id>WWIC/2016/02</secondary_id>
    <nct_id>NCT03275831</nct_id>
  </id_info>
  <brief_title>PluroGel on Wounds of Mixed Etiology</brief_title>
  <official_title>A Pilot Study to Investigate the Efficacy of PluroGel in Healing Venous and Mixed Aetiology Leg Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medline Industries</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>
      A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in&#xD;
      healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg&#xD;
      ulcers will be identified from hospital outpatient clinics. Willing patients meeting the&#xD;
      inclusion and exclusion criteria will be consented and assessed in line with standard care.&#xD;
      Participants will be randomized at Week 2 to receive either topical PluroGel or Intrasite gel&#xD;
      (an alternative topical hydrogel product) if inclusion criteria is met.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a pilot, randomized, controlled, multi-center trial to determine the&#xD;
      effectiveness of PluroGel in the reduction of size of wounds and reduction of slough covering&#xD;
      the wound surface compared with Intrasite Gel. The primary objectives will be to evaluate the&#xD;
      effectiveness of PluroGel compared with Intrasite Gel in the reduction of size of venous leg&#xD;
      ulcers or mixed venous arterial aetiology. Also the reduction in the percentage of slough&#xD;
      covering the wound bed in both groups will be compared. The secondary objective will be to&#xD;
      evaluate patient comfort, satisfaction and acceptance of the hydrogels along with staff&#xD;
      feedback of both hydrogels. Patients with either a venous leg ulcer (VLU) or an mixed venous&#xD;
      arterial aetiology (MAU) leg ulcer will be identified by the participant's health care&#xD;
      provider and will be treated with PluroGel or Intrasite Gel. A total of 40 subjects will be&#xD;
      enrolled to the study, 20 to each arm. These subjects will be recruited from patients&#xD;
      receiving treatment for wounds at NHS outpatient clinic. Participants will be approached&#xD;
      initially by the NHS care-giver and asked if interested in participating in research. If&#xD;
      interested, participants will be asked to sign a permission to contact form for contact&#xD;
      details to be given to a member of the research team who would then contact the participant&#xD;
      to provide further information. A screening log will be kept of all patients who have been&#xD;
      considered but who do not fulfill the criteria for entry. Patients will be randomized to&#xD;
      either Plurogel and standard care or Intrasite Gel in conjunction with standard care, on an&#xD;
      equal basis. Subjects will be eligible for randomization if during the first two weeks within&#xD;
      the study the target wound has not reduced in surface area by 30% or more and there has been&#xD;
      a less than 25% reduction in the cover of the wound bed with visible slough. Once the subject&#xD;
      has completed 4-weeks of treatment, and the final visit, or the target ulcer has healed,&#xD;
      whichever is soonest, then the subject has completed the study and the termination form will&#xD;
      be completed. The Investigator will ensure that all CRF forms are completed and accurate. The&#xD;
      study end date will be the date of the last subject's last visit. The CI and study sponsor,&#xD;
      will comply with any safety reporting obligations for serious adverse device related events&#xD;
      to the manufacturer, study sponsor, R&amp;D Department(s) of the University Health Board(s) and&#xD;
      the Ethics Committee, as defined in the applicable laws and regulations, and within the&#xD;
      required timelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">October 5, 2021</completion_date>
  <primary_completion_date type="Actual">October 5, 2021</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>Change in wound size</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of change in wound surface area (cm2) over a 4 week assessment between baseline and final assessment in PluroGel treated group compared to Intrasite treated group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in average percent reduction of slough in wound bed over 4 week treatment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of change in average percent reduction of slough present in the wound bed observed at baseline and over 4 week treatment period in PluroGel treated group compared to Intrasite treated group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient evaluation</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Survey questions to report adherence to protocol of care, comfort, comparison with previous treatments, level of patient discomfort and pain during use of either PluroGel or Intrasite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff evaluation</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Venous Ulcer</condition>
  <condition>Arterial Ulcer</condition>
  <arm_group>
    <arm_group_label>Intrasite Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intrasite Gel is an effective method for hydrating dry necrotic and sloughy wounds. It is an amorphous gel that contains 85% water, and gently increases the moisture level within the wound, encouraging moist wound healing through autolytic debridement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PluroGel Burn and Wound Dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PluroGel</intervention_name>
    <description>Surfactant based gel</description>
    <arm_group_label>PluroGel Burn and Wound Dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrasite gel</intervention_name>
    <description>Hydrogel</description>
    <arm_group_label>Intrasite Gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥ 18 years old&#xD;
&#xD;
          -  Patients with a non-healing venous leg ulcer or mixed aetiology ulcer.&#xD;
&#xD;
          -  Duration of wound ≥ 6 weeks ≤ 5 years&#xD;
&#xD;
          -  Wound is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm&#xD;
&#xD;
          -  Presence of at least 25% visible slough within the wound bed&#xD;
&#xD;
          -  The patient must be able to understand the study and provide written informed consent&#xD;
&#xD;
          -  No clinical signs of infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any of the wound dressings or compression bandaging to be&#xD;
             used in the trial&#xD;
&#xD;
          -  Current local or systemic antibiotics in the week prior to inclusion&#xD;
&#xD;
          -  Clinically infected wound as determined by the presence of 3 or more of the following&#xD;
             clinical signs: perilesional erythema, pain between two dressing changes, malodorous&#xD;
             wound, abundant exudate and oedema.&#xD;
&#xD;
          -  Prolonged treatment with immunosuppressive agents or high dose corticosteroids&#xD;
&#xD;
          -  Patients who have a current illness or condition which may interfere with wound&#xD;
             healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease&#xD;
             or alcohol or drug abuse)&#xD;
&#xD;
          -  Patients who have participated in a clinical trial on wound healing within the past&#xD;
             month&#xD;
&#xD;
          -  Patients with a known history of non-adherence with medical treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aneurin Bevan University Health Board</name>
      <address>
        <city>Newport</city>
        <state>South Wales</state>
        <zip>NP20 4SZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff &amp; Vale University Health Board</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Callam MJ, Harper DR, Dale JJ, Ruckley CV. Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):929-31. doi: 10.1136/bmj.294.6577.929.</citation>
    <PMID>3107659</PMID>
  </reference>
  <reference>
    <citation>Connor-Ballard PA. Understanding and managing burn pain: Part 2. Am J Nurs. 2009 May;109(5):54-62; quiz 63. doi: 10.1097/01.NAJ.0000351510.77627.db.</citation>
    <PMID>19411907</PMID>
  </reference>
  <reference>
    <citation>Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. doi: 10.1002/14651858.CD000265.</citation>
    <PMID>10908469</PMID>
  </reference>
  <reference>
    <citation>Gottrup F, Apelqvist J, Price P; European Wound Management Association Patient Outcome Group. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010 Jun;19(6):237-68. doi: 10.12968/jowc.2010.19.6.48471.</citation>
    <PMID>20551864</PMID>
  </reference>
  <reference>
    <citation>Hunter RL, Luo AZ, Zhang R, Kozar RA, Moore FA. Poloxamer 188 inhibition of ischemia/reperfusion injury: evidence for a novel anti-adhesive mechanism. Ann Clin Lab Sci. 2010 Spring;40(2):115-25.</citation>
    <PMID>20421622</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</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>Varicose Ulcer</mesh_term>
    <mesh_term>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/NCT03275831
org study id: R17-006
secondary id: WWIC/2016/02
nct id: NCT03275831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in
      healing venous and mixed aetiology leg ulcers. Patients with venous and mixed aetiology leg
      ulcers will be identified from hospital outpatient clinics. Willing patients meeting the
      inclusion and exclusion criteria will be consented and assessed in line with standard care.
      Participants will be randomized at Week 2 to receive either topical PluroGel or Intrasite gel
      (an alternative topical hydrogel product) if inclusion criteria is met.
This will be a pilot, randomized, controlled, multi-center trial to determine the
      effectiveness of PluroGel in the reduction of size of wounds and reduction of slough covering
      the wound surface compared with Intrasite Gel. The primary objectives will be to evaluate the
      effectiveness of PluroGel compared with Intrasite Gel in the reduction of size of venous leg
      ulcers or mixed venous arterial aetiology. Also the reduction in the percentage of slough
      covering the wound bed in both groups will be compared. The secondary objective will be to
      evaluate patient comfort, satisfaction and acceptance of the hydrogels along with staff
      feedback of both hydrogels. Patients with either a venous leg ulcer (VLU) or an mixed venous
      arterial aetiology (MAU) leg ulcer will be identified by the participant's health care
      provider and will be treated with PluroGel or Intrasite Gel. A total of 40 subjects will be
      enrolled to the study, 20 to each arm. These subjects will be recruited from patients
      receiving treatment for wounds at NHS outpatient clinic. Participants will be approached
      initially by the NHS care-giver and asked if interested in participating in research. If
      interested, participants will be asked to sign a permission to contact form for contact
      details to be given to a member of the research team who would then contact the participant
      to provide further information. A screening log will be kept of all patients who have been
      considered but who do not fulfill the criteria for entry. Patients will be randomized to
      either Plurogel and standard care or Intrasite Gel in conjunction with standard care, on an
      equal basis. Subjects will be eligible for randomization if during the first two weeks within
      the study the target wound has not reduced in surface area by 30% or more and there has been
      a less than 25% reduction in the cover of the wound bed with visible slough. Once the subject
      has completed 4-weeks of treatment, and the final visit, or the target ulcer has healed,
      whichever is soonest, then the subject has completed the study and the termination form will
      be completed. The Investigator will ensure that all CRF forms are completed and accurate. The
      study end date will be the date of the last subject's last visit. The CI and study sponsor,
      will comply with any safety reporting obligations for serious adverse device related events
      to the manufacturer, study sponsor, R&D Department(s) of the University Health Board(s) and
      the Ethics Committee, as defined in the applicable laws and regulations, and within the
      required timelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in wound size
time frame: 4 weeks
description: Comparison of change in wound surface area (cm2) over a 4 week assessment between baseline and final assessment in PluroGel treated group compared to Intrasite treated group.
measure: Change in average percent reduction of slough in wound bed over 4 week treatment
time frame: 4 weeks
description: Comparison of change in average percent reduction of slough present in the wound bed observed at baseline and over 4 week treatment period in PluroGel treated group compared to Intrasite treated group
measure: Patient evaluation
time frame: Up to 6 weeks
description: Survey questions to report adherence to protocol of care, comfort, comparison with previous treatments, level of patient discomfort and pain during use of either PluroGel or Intrasite
measure: Staff evaluation
time frame: Up to 6 weeks
description: Survey to record staff feedback including ease of application and removal of both PluroGel and the comparator Intrasite.
arm group label: Intrasite Gel
arm group type: Active Comparator
description: Intrasite Gel is an effective method for hydrating dry necrotic and sloughy wounds. It is an amorphous gel that contains 85% water, and gently increases the moisture level within the wound, encouraging moist wound healing through autolytic debridement.
arm group label: PluroGel Burn and Wound Dressing
arm group type: Experimental
description: PluroGel contains a surfactant-based cleanser to assist wound debridement and cleansing
intervention type: Device
intervention name: PluroGel
description: Surfactant based gel
arm group label: PluroGel Burn and Wound Dressing
intervention type: Device
intervention name: Intrasite gel
description: Hydrogel
arm group label: Intrasite Gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United Kingdom
citation: Callam MJ, Harper DR, Dale JJ, Ruckley CV. Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):929-31. doi: 10.1136/bmj.294.6577.929.
PMID: 3107659
citation: Connor-Ballard PA. Understanding and managing burn pain: Part 2. Am J Nurs. 2009 May;109(5):54-62; quiz 63. doi: 10.1097/01.NAJ.0000351510.77627.db.
PMID: 19411907
citation: Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2000;(3):CD000265. doi: 10.1002/14651858.CD000265.
PMID: 10908469
citation: Gottrup F, Apelqvist J, Price P; European Wound Management Association Patient Outcome Group. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. J Wound Care. 2010 Jun;19(6):237-68. doi: 10.12968/jowc.2010.19.6.48471.
PMID: 20551864
citation: Hunter RL, Luo AZ, Zhang R, Kozar RA, Moore FA. Poloxamer 188 inhibition of ischemia/reperfusion injury: evidence for a novel anti-adhesive mechanism. Ann Clin Lab Sci. 2010 Spring;40(2):115-25.
PMID: 20421622
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Ulcer
sharing ipd: No