<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/NCT03825263</url>
  </required_header>
  <id_info>
    <org_study_id>IMPRESS</org_study_id>
    <nct_id>NCT03825263</nct_id>
  </id_info>
  <brief_title>Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema</brief_title>
  <acronym>IMPRESS</acronym>
  <official_title>Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cwm Taf University Health Board (NHS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Wales</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>
      The treatment of lymphoedema and its associated complications represent a considerable drain&#xD;
      on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the&#xD;
      LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but&#xD;
      the efficacy of this device needs to be investigated via robust clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This feasibility study aims to evaluate a proposed methodology designed to assess the&#xD;
      efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot&#xD;
      randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema&#xD;
      care alone. Feasibility outcomes included impact on lower limb volume.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</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>
    <intervention_model_description>Observational control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower Limb Volume</measure>
    <time_frame>3 and 6 months of treatment</time_frame>
    <description>Change in limb volume</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of IPC use on the Quality of Life: QOL Scores</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Change in QOL Scores. Using the Quality of LifeEnjoyment and Satisfication Questionairre short form (Q-LES-Q-SF) with 14 items. Score range is from 14 to 70.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Perometer</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of limb volume measurement methods</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Lymphoedema</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receive normal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intermittent Pressure Compression</intervention_name>
    <description>The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Lymphassist</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or over,&#xD;
&#xD;
          -  Able to provide written consent,&#xD;
&#xD;
          -  Confirmed diagnosis of lower limb ISL stage II or III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any of these conditions&#xD;
&#xD;
          -  Severe congestive heart failure&#xD;
&#xD;
          -  Severe skin problems, lower limb ulcers or wounds.&#xD;
&#xD;
          -  Presence of cognitive impairment (permanent or intermittent) which would prevent&#xD;
             patients from using the IPC device safely or adhering to instructions/study protocol.&#xD;
&#xD;
          -  Non-pitting chronic lymphoedema.&#xD;
&#xD;
          -  Known or suspected deep vein thrombosis.&#xD;
&#xD;
          -  Pulmonary embolism.&#xD;
&#xD;
          -  Thrombophlebitis.&#xD;
&#xD;
          -  Acute inflammation of the skin (erysipelas, cellulitis).&#xD;
&#xD;
          -  Uncontrolled/severe cardiac failure.&#xD;
&#xD;
          -  Pulmonary oedema.&#xD;
&#xD;
          -  Ischaemic vascular disease.&#xD;
&#xD;
          -  Active cancer diagnosis.&#xD;
&#xD;
          -  Active metastatic diseases affecting the oedematous region.&#xD;
&#xD;
          -  Oedema at the root of the extremity or truncal oedema.&#xD;
&#xD;
          -  Severe peripheral neuropathy.&#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>Mark Williams, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Wales</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dewi Sant Hospital</name>
      <address>
        <city>Pontypridd</city>
        <state>RCT</state>
        <zip>CF37 1LB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</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>Lymphedema</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/NCT03825263
org study id: IMPRESS
nct id: NCT03825263
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The treatment of lymphoedema and its associated complications represent a considerable drain
      on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the
      LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but
      the efficacy of this device needs to be investigated via robust clinical research.
This feasibility study aims to evaluate a proposed methodology designed to assess the
      efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot
      randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema
      care alone. Feasibility outcomes included impact on lower limb volume.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Observational control trial
primary purpose: Treatment
masking: None (Open Label)
measure: Lower Limb Volume
time frame: 3 and 6 months of treatment
description: Change in limb volume
measure: Assessment of IPC use on the Quality of Life: QOL Scores
time frame: 3 and 6 months
description: Change in QOL Scores. Using the Quality of LifeEnjoyment and Satisfication Questionairre short form (Q-LES-Q-SF) with 14 items. Score range is from 14 to 70.
measure: Use of Perometer
time frame: 6 months
description: Comparison of limb volume measurement methods
arm group label: Control
arm group type: No Intervention
description: Participants receive normal treatment
arm group label: Intervention
arm group type: Experimental
description: Participants administer Intermittent Pressure Compression using the Lymphassist in addition to normal treatment
intervention type: Device
intervention name: Intermittent Pressure Compression
description: The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.
arm group label: Intervention
other name: Lymphassist
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Williams, Phd
role: Principal Investigator
affiliation: University of South Wales
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lymphedema
sharing ipd: No