<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/NCT04492046</url>
  </required_header>
  <id_info>
    <org_study_id>Lipedema</org_study_id>
    <nct_id>NCT04492046</nct_id>
  </id_info>
  <brief_title>Complex Decongestive Applications in Patients With Lipedema</brief_title>
  <official_title>The Effect of Complex Decongestive Applications on Lower Extremity Limb Volume in Patients With Lipedema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</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>
      Lipedema is a rare condition which almost exclusively affects women. The disease is&#xD;
      characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is&#xD;
      often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and&#xD;
      lower legs are affected. Upper extremity involvement has been reported to be present in 80%&#xD;
      patients. The hands and feet are never affected. The accumulation of subcutaneous fat and&#xD;
      edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also&#xD;
      tend to bruise easily even after a minimal trauma. It has been reported that the complaint of&#xD;
      pain increases with aging.There is no known cure for lipedema. However, conservative&#xD;
      treatment with physiotherapy, manual lymph drainage and compression, also known as complex&#xD;
      decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of&#xD;
      this study is to investigate the effect of complex decongestive applications on lower&#xD;
      extremity limb circumference and volume in patients with lipedema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants included in the study were included in a treatment protocol consisting of&#xD;
      complex decongestive physiotherapy Each patient received;&#xD;
&#xD;
        1. 45 minutes of manual lymph drainage on both lower extremities,&#xD;
&#xD;
        2. Moisturisation of the lower extremities,&#xD;
&#xD;
        3. Bandage application&#xD;
&#xD;
      Alongside this routine, the patients were advised to exercise (walk) regularly every day.&#xD;
&#xD;
      This treatment routine was continued until the patients were discharged from the clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2019</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Weeks</target_duration>
  <primary_outcome>
    <measure>Limb Volume</measure>
    <time_frame>Change from Baseline limb volume at 6 weeks</time_frame>
    <description>In measurement of limb volume, the perometer was used. The device measures limb volume via infrared light and it has been reported to be a quick and reliable method. The device has a square frame which is used to surround the perimeter of the limb. The limb interrupts the emitted infrared beams that would normally be sensed by the light-sensing diodes in the two planes. Thus two perpendicular diameter measurements of the limb for the measured segment are provided. The device estimates the opposite two sides based on an elliptical cross-section.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Lipedema</condition>
  <arm_group>
    <arm_group_label>Complex Decongestive physiotherapy</arm_group_label>
    <description>All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Lymph Drainage</intervention_name>
    <description>Manual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes.</description>
    <arm_group_label>Complex Decongestive physiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bandaging</intervention_name>
    <description>Multilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application.</description>
    <arm_group_label>Complex Decongestive physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients included in this study consisted of those who had a diagnosis of lipedema in the&#xD;
        lower extremities, between the ages of 18-65.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being willing to participate in the study&#xD;
&#xD;
          -  Being 18-65 years old&#xD;
&#xD;
          -  Having a diagnosis of lower extremity lipedema&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Having edematous disease in the lower extremity such as lymphedema or chronic venous&#xD;
        insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gokhan Yazici, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University</name>
      <address>
        <city>Ankara</city>
        <state>Çankaya</state>
        <zip>06650</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Gokhan Yazici</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lipedema</keyword>
  <keyword>Manual lymph drainage</keyword>
  <keyword>Complex Decongestive Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lipedema</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/NCT04492046
org study id: Lipedema
nct id: NCT04492046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lipedema is a rare condition which almost exclusively affects women. The disease is
      characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is
      often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and
      lower legs are affected. Upper extremity involvement has been reported to be present in 80%
      patients. The hands and feet are never affected. The accumulation of subcutaneous fat and
      edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also
      tend to bruise easily even after a minimal trauma. It has been reported that the complaint of
      pain increases with aging.There is no known cure for lipedema. However, conservative
      treatment with physiotherapy, manual lymph drainage and compression, also known as complex
      decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of
      this study is to investigate the effect of complex decongestive applications on lower
      extremity limb circumference and volume in patients with lipedema.
All participants included in the study were included in a treatment protocol consisting of
      complex decongestive physiotherapy Each patient received;

        1. 45 minutes of manual lymph drainage on both lower extremities,

        2. Moisturisation of the lower extremities,

        3. Bandage application

      Alongside this routine, the patients were advised to exercise (walk) regularly every day.

      This treatment routine was continued until the patients were discharged from the clinic.
observational model: Case-Only
time perspective: Prospective
measure: Limb Volume
time frame: Change from Baseline limb volume at 6 weeks
description: In measurement of limb volume, the perometer was used. The device measures limb volume via infrared light and it has been reported to be a quick and reliable method. The device has a square frame which is used to surround the perimeter of the limb. The limb interrupts the emitted infrared beams that would normally be sensed by the light-sensing diodes in the two planes. Thus two perpendicular diameter measurements of the limb for the measured segment are provided. The device estimates the opposite two sides based on an elliptical cross-section.
arm group label: Complex Decongestive physiotherapy
description: All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.
intervention type: Other
intervention name: Manual Lymph Drainage
description: Manual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes.
arm group label: Complex Decongestive physiotherapy
intervention type: Other
intervention name: Bandaging
description: Multilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application.
arm group label: Complex Decongestive physiotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Gokhan Yazici, PhD
role: Principal Investigator
affiliation: Gazi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Gokhan Yazici
investigator title: Principal Investigator
mesh term: Lipedema
sharing ipd: No