<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/NCT02234674</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00355-42</org_study_id>
    <nct_id>NCT02234674</nct_id>
  </id_info>
  <brief_title>Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema</brief_title>
  <official_title>Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stendo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stendo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a&#xD;
      leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).&#xD;
&#xD;
      This study is a pilot controlled randomized study with two arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>volume of the most affected leg</measure>
    <time_frame>baseline ; after 5 days intensive CDP</time_frame>
    <description>Change in % of the volume of the most affected leg according to disk model method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>baseline ; after 5 days intensive CDP</time_frame>
    <description>36 health survey questionnaire (SF-36) and Visual Analogical Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Primary Lower Limb Lymphedema</condition>
  <condition>Secondary Lower Limb Lymphedema</condition>
  <arm_group>
    <arm_group_label>Standard intensive CDP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stendo group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Current intensive CDP</intervention_name>
    <description>Standard Intensive CDP including&#xD;
manual lymph drainage,&#xD;
pressotherapy and&#xD;
bandaging</description>
    <arm_group_label>Standard intensive CDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intensive CDP where Stendo pulsating suit replaces pressotherapy</intervention_name>
    <description>The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.</description>
    <arm_group_label>Stendo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of&#xD;
             one or two legs.&#xD;
&#xD;
          -  Patient with a lympedema stage II (persistent) or III according to the classification&#xD;
             of the International Society of Lymphoedema (ISL)&#xD;
&#xD;
          -  Patient aged 18 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a severe heart, kidney or liver failure,&#xD;
&#xD;
          -  Patient with an advanced obstructive arterial disease&#xD;
&#xD;
          -  Patient with a recent and progressive deep venous thrombosis&#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>CHIC Des Andaines</name>
      <address>
        <city>La FERTE MACE</city>
        <zip>61600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.</citation>
    <PMID>17539462</PMID>
  </results_reference>
  <results_reference>
    <citation>Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.</citation>
    <PMID>17684090</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulsating suit</keyword>
  <keyword>lymphedema</keyword>
  <keyword>leg volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</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/NCT02234674
org study id: 2014-A00355-42
nct id: NCT02234674
lead sponsor: 
has dmc: Yes
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a
      leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

      This study is a pilot controlled randomized study with two arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: volume of the most affected leg
time frame: baseline ; after 5 days intensive CDP
description: Change in % of the volume of the most affected leg according to disk model method
measure: Quality of Life
time frame: baseline ; after 5 days intensive CDP
description: 36 health survey questionnaire (SF-36) and Visual Analogical Scale
arm group label: Standard intensive CDP
arm group type: Active Comparator
description: This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
arm group label: Stendo group
arm group type: Experimental
description: This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.
intervention type: Other
intervention name: Current intensive CDP
description: Standard Intensive CDP including
manual lymph drainage,
pressotherapy and
bandaging
arm group label: Standard intensive CDP
intervention type: Other
intervention name: intensive CDP where Stendo pulsating suit replaces pressotherapy
description: The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
arm group label: Stendo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.
PMID: 17539462
citation: Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
PMID: 17684090
responsible party type: Sponsor
mesh term: Lymphedema