<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/NCT04461132</url>
  </required_header>
  <id_info>
    <org_study_id>09.2017.209</org_study_id>
    <nct_id>NCT04461132</nct_id>
  </id_info>
  <brief_title>The Effect of Manual Lymphatic Drainage</brief_title>
  <official_title>Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istanbul Health Sciences University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</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>
      In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual&#xD;
      lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector&#xD;
      and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation,&#xD;
      enabling nutrients and oxygen to reach tissues and at the same time removing residual&#xD;
      substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD,&#xD;
      we could stimulate healing of ulcer. The aim of this study to investigate the effect of&#xD;
      manual lymphatic drainage on venous ulcer healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2018</start_date>
  <completion_date type="Actual">May 29, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</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>prospective randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of wound healing</measure>
    <time_frame>Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.</time_frame>
    <description>Wound was assesed by analyzing photographes of wound with Tracker software.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of range of motion of ankle</measure>
    <time_frame>Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.</time_frame>
    <description>range of motion of ankle was measured with goniometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.</time_frame>
    <description>Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluation of edema</measure>
    <time_frame>Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.</time_frame>
    <description>edema was measured by 3D scanner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluation of quality of life</measure>
    <time_frame>Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.</time_frame>
    <description>quality of life was evaluated by SF- 12</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Venous Leg Ulcer</condition>
  <condition>Venous Insufficiency</condition>
  <condition>Lymphatic Disease</condition>
  <arm_group>
    <arm_group_label>Manual Lymphatic Drainage Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included manual lymphatic drainage on the leg, skin care, bandaging and exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shame Manual Lymphatic Drainage Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included shame manual lymphatic drainage on the leg, skin care, bandaging and exercise. Shame manual lymphatic drainage include light touches instead of real manual lymphatic drainage techniques</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Lymphatic drainage (MLD)</intervention_name>
    <description>MLD vith vodder technique was applied to leg</description>
    <arm_group_label>Manual Lymphatic Drainage Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skin Care</intervention_name>
    <description>Wound was cleaned with salin and covered by dressing without including active products</description>
    <arm_group_label>Manual Lymphatic Drainage Group</arm_group_label>
    <arm_group_label>Shame Manual Lymphatic Drainage Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>breathing and foot pump exercise was prescribed</description>
    <arm_group_label>Manual Lymphatic Drainage Group</arm_group_label>
    <arm_group_label>Shame Manual Lymphatic Drainage Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shame Manual Lymphatic drainage</intervention_name>
    <description>manual lymphatic drainage was applied with light touch instead of real mld techniques</description>
    <arm_group_label>Shame Manual Lymphatic Drainage Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with venous ulcer unhealing for at least 6 weeks&#xD;
&#xD;
          -  Without enfection&#xD;
&#xD;
          -  vascular surgery is not indicated&#xD;
&#xD;
          -  There is no obstruction to apply MLD and compression to lower extremty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with diabetic mellutus&#xD;
&#xD;
          -  with enfection&#xD;
&#xD;
          -  with ABI&lt;0,7&#xD;
&#xD;
          -  Patients who have undergone venous vascular surgery&#xD;
&#xD;
          -  Patients undergoing active wound closure treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilüfer Kablan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Health science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Saglık Bilimleri University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Azoubel R, Torres Gde V, da Silva LW, Gomes FV, dos Reis LA. [Effects of the decongestive physiotherapy in the healing of venous ulcers]. Rev Esc Enferm USP. 2010 Dec;44(4):1085-92. doi: 10.1590/s0080-62342010000400033. Portuguese.</citation>
    <PMID>21337794</PMID>
  </results_reference>
  <results_reference>
    <citation>Crawford JM, Lal BK, Duran WN, Pappas PJ. Pathophysiology of venous ulceration. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):596-605. doi: 10.1016/j.jvsv.2017.03.015.</citation>
    <PMID>28624002</PMID>
  </results_reference>
  <results_reference>
    <citation>de Roos KP, Wittens CH, Maessen-Visch MB, van der Wegen-Franken CP. [Universal Dutch guideline on 'Venous disease']. Ned Tijdschr Geneeskd. 2014;158(0):A8076. Dutch.</citation>
    <PMID>27707417</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. doi: 10.12968/bjcn.2010.15.Sup3.47365.</citation>
    <PMID>20559172</PMID>
  </results_reference>
  <results_reference>
    <citation>Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.</citation>
    <PMID>26025146</PMID>
  </results_reference>
  <results_reference>
    <citation>Hampton S. An introduction to various types of leg ulcers and their management. Br J Nurs. 2006 Jun 8-21;15(11):S9-13. doi: 10.12968/bjon.2006.15.Sup2.21235.</citation>
    <PMID>16835515</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</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>Venous Insufficiency</mesh_term>
    <mesh_term>Lymphatic Diseases</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04461132
org study id: 09.2017.209
nct id: NCT04461132
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual
      lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector
      and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation,
      enabling nutrients and oxygen to reach tissues and at the same time removing residual
      substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD,
      we could stimulate healing of ulcer. The aim of this study to investigate the effect of
      manual lymphatic drainage on venous ulcer healing.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of wound healing
time frame: Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.
description: Wound was assesed by analyzing photographes of wound with Tracker software.
measure: Evaluation of range of motion of ankle
time frame: Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.
description: range of motion of ankle was measured with goniometer
measure: Evaluation of pain
time frame: Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.
description: Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.
measure: evaluation of edema
time frame: Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.
description: edema was measured by 3D scanner
measure: evaluation of quality of life
time frame: Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.
description: quality of life was evaluated by SF- 12
arm group label: Manual Lymphatic Drainage Group
arm group type: Active Comparator
description: All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included manual lymphatic drainage on the leg, skin care, bandaging and exercise.
arm group label: Shame Manual Lymphatic Drainage Group
arm group type: Sham Comparator
description: All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included shame manual lymphatic drainage on the leg, skin care, bandaging and exercise. Shame manual lymphatic drainage include light touches instead of real manual lymphatic drainage techniques
intervention type: Other
intervention name: Manual Lymphatic drainage (MLD)
description: MLD vith vodder technique was applied to leg
arm group label: Manual Lymphatic Drainage Group
intervention type: Other
intervention name: Skin Care
description: Wound was cleaned with salin and covered by dressing without including active products
arm group label: Manual Lymphatic Drainage Group
arm group label: Shame Manual Lymphatic Drainage Group
intervention type: Other
intervention name: Exercise
description: breathing and foot pump exercise was prescribed
arm group label: Manual Lymphatic Drainage Group
arm group label: Shame Manual Lymphatic Drainage Group
intervention type: Other
intervention name: Shame Manual Lymphatic drainage
description: manual lymphatic drainage was applied with light touch instead of real mld techniques
arm group label: Shame Manual Lymphatic Drainage Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nilüfer Kablan, PhD
role: Study Director
affiliation: University of Health science
facility: 
country: Turkey
citation: Azoubel R, Torres Gde V, da Silva LW, Gomes FV, dos Reis LA. [Effects of the decongestive physiotherapy in the healing of venous ulcers]. Rev Esc Enferm USP. 2010 Dec;44(4):1085-92. doi: 10.1590/s0080-62342010000400033. Portuguese.
PMID: 21337794
citation: Crawford JM, Lal BK, Duran WN, Pappas PJ. Pathophysiology of venous ulceration. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):596-605. doi: 10.1016/j.jvsv.2017.03.015.
PMID: 28624002
citation: de Roos KP, Wittens CH, Maessen-Visch MB, van der Wegen-Franken CP. [Universal Dutch guideline on 'Venous disease']. Ned Tijdschr Geneeskd. 2014;158(0):A8076. Dutch.
PMID: 27707417
citation: Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. doi: 10.12968/bjcn.2010.15.Sup3.47365.
PMID: 20559172
citation: Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.
PMID: 26025146
citation: Hampton S. An introduction to various types of leg ulcers and their management. Br J Nurs. 2006 Jun 8-21;15(11):S9-13. doi: 10.12968/bjon.2006.15.Sup2.21235.
PMID: 16835515
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Venous Insufficiency
mesh term: Lymphatic Diseases
mesh term: Leg Ulcer
sharing ipd: Undecided