<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/NCT01716273</url>
  </required_header>
  <id_info>
    <org_study_id>RRK4106</org_study_id>
    <nct_id>NCT01716273</nct_id>
  </id_info>
  <brief_title>Use of White Granulated Sugar on Wounds</brief_title>
  <official_title>A Randomised Controlled Trial to Investigate the Clinical and Cost-effectiveness of White Granulated Sugar Dressing Compared With Standard Treatment in the Management of Exudating Wounds With Parallel Economic Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moses Murandu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoires URGO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wolverhampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating&#xD;
      wounds compared with standard treatment?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients for whom all the following apply:&#xD;
&#xD;
      Have an exudating wound sizes 5cm2 and 40cm2 A minimum of 25% slough, infected and necrotic&#xD;
      tissue No dry necrotic eschar present Ankle Brachial Pressure Index of greater than 0.6 Are&#xD;
      over 18 years Independently and willingly consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2011</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to debridement of wound</measure>
    <time_frame>4 weeks</time_frame>
    <description>wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in wound surface area</measure>
    <time_frame>4 weeks</time_frame>
    <description>Wound measurements will be taken at entry into the study then weekly until end of 4 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 weeks</time_frame>
    <description>Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Infected Wounds</condition>
  <arm_group>
    <arm_group_label>Chronic &amp; Acute infected wounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wound will be cleaned with normal saline or tap water and Granulated sugar will be applied directly to the wound and covered with an absorbent pad and held in place with a bandage and tape.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic and Acute infected wounds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wound will be cleaned with normal saline or tap water and an appropriate debridement dressing (Aquacel or Sorbsan) is applied to the wound and secured with a bandage and surgical tape.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Granulated Sugar</intervention_name>
    <description>30 grams of granulated sugar is used to cover the wound area and this is held in place using a dry dressing pad , bandage and tape.</description>
    <arm_group_label>Chronic &amp; Acute infected wounds</arm_group_label>
    <arm_group_label>Chronic and Acute infected wounds</arm_group_label>
    <other_name>Sucrose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Debridement Dressing</intervention_name>
    <description>1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.</description>
    <arm_group_label>Chronic &amp; Acute infected wounds</arm_group_label>
    <arm_group_label>Chronic and Acute infected wounds</arm_group_label>
    <other_name>Aquacel or Sorbsan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Exudating wound sizes 5cm2 and 40cm2&#xD;
&#xD;
          -  A minimum of 25% slough, infected and necrotic tissue&#xD;
&#xD;
          -  No dry necrotic eschar&#xD;
&#xD;
          -  Ankle Brachial Pressure Index of greater than 0.6&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Able to independently and willingly consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants in a trial evaluating other therapies for their wound&#xD;
&#xD;
          -  Have previously been in this trial&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Participants not able to tolerate daily dressing change&#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>Malcolm Simms, MBBSFRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Birmingham NHS Fondation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moses Murandu, PhD student</last_name>
    <role>Study Director</role>
    <affiliation>University of Wolverhampton</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Moses Murandu, PhD student</last_name>
    <phone>07743025072</phone>
    <email>mosesmurandu@wlv.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Malcolm Simms, MBBSFRCS</last_name>
    <phone>07768147025</phone>
    <email>malcolm.simms@uhb.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Hornabrook</last_name>
      <phone>0121 697 8311</phone>
      <email>rachel.hornabrook@uhb.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Carol Dealey, PhD</last_name>
      <phone>0121 697 8311</phone>
      <email>carol.dealey@uhb.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Moses Murandu, PhD student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Murandu M, Webber MA, Simms MH, Dealey C. Use of granulated sugar therapy in the management of sloughy or necrotic wounds: a pilot study. J Wound Care. 2011 May;20(5):206, 208, 210 passim. doi: 10.12968/jowc.2011.20.5.206.</citation>
    <PMID>21647066</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Birmingham</investigator_affiliation>
    <investigator_full_name>Moses Murandu</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboxymethylcellulose Sodium</mesh_term>
  </intervention_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/NCT01716273
org study id: RRK4106
nct id: NCT01716273
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating
      wounds compared with standard treatment?
Patients for whom all the following apply:

      Have an exudating wound sizes 5cm2 and 40cm2 A minimum of 25% slough, infected and necrotic
      tissue No dry necrotic eschar present Ankle Brachial Pressure Index of greater than 0.6 Are
      over 18 years Independently and willingly consent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Time to debridement of wound
time frame: 4 weeks
description: wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
measure: Reduction in wound surface area
time frame: 4 weeks
description: Wound measurements will be taken at entry into the study then weekly until end of 4 weeks
measure: Quality of life
time frame: 4 weeks
description: Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks
arm group label: Chronic & Acute infected wounds
arm group type: Experimental
description: Wound will be cleaned with normal saline or tap water and Granulated sugar will be applied directly to the wound and covered with an absorbent pad and held in place with a bandage and tape.
arm group label: Chronic and Acute infected wounds
arm group type: Active Comparator
description: Wound will be cleaned with normal saline or tap water and an appropriate debridement dressing (Aquacel or Sorbsan) is applied to the wound and secured with a bandage and surgical tape.
intervention type: Other
intervention name: Granulated Sugar
description: 30 grams of granulated sugar is used to cover the wound area and this is held in place using a dry dressing pad , bandage and tape.
arm group label: Chronic & Acute infected wounds
arm group label: Chronic and Acute infected wounds
other name: Sucrose
intervention type: Other
intervention name: Debridement Dressing
description: 1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.
arm group label: Chronic & Acute infected wounds
arm group label: Chronic and Acute infected wounds
other name: Aquacel or Sorbsan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malcolm Simms, MBBSFRCS
role: Principal Investigator
affiliation: University Hospital Birmingham NHS Fondation Trust
last name: Moses Murandu, PhD student
role: Study Director
affiliation: University of Wolverhampton
last name: Moses Murandu, PhD student
phone: 07743025072
email: mosesmurandu@wlv.ac.uk
last name: Malcolm Simms, MBBSFRCS
phone: 07768147025
email: malcolm.simms@uhb.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
citation: Murandu M, Webber MA, Simms MH, Dealey C. Use of granulated sugar therapy in the management of sloughy or necrotic wounds: a pilot study. J Wound Care. 2011 May;20(5):206, 208, 210 passim. doi: 10.12968/jowc.2011.20.5.206.
PMID: 21647066
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital Birmingham
investigator full name: Moses Murandu
investigator title: PhD student
mesh term: Wound Infection
mesh term: Wounds and Injuries
mesh term: Carboxymethylcellulose Sodium