<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/NCT03039517</url>
  </required_header>
  <id_info>
    <org_study_id>15-01178</org_study_id>
    <nct_id>NCT03039517</nct_id>
  </id_info>
  <brief_title>Post Thrombotic Syndrome Prevention Study</brief_title>
  <official_title>Post Thrombotic Syndrome Prevention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two arm, prospective, single center, randomized clinical trial. Subjects will be&#xD;
      randomly assigned into one of two groups using block randomization technique in a 1:1 ratio.&#xD;
      The control group will receive care using elastic compression stocking and the intervention&#xD;
      group will use the ACTitouch device. Stratified randomization will occur based on whether the&#xD;
      Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for&#xD;
      2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if use of a pneumatic compression device&#xD;
      (ACTitouch, Tactile Medical) is beneficial in improving or preventing the development of Post&#xD;
      Thrombotic Syndrome (PTS). 84 patients who have a history of an acute proximal unilateral leg&#xD;
      DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal&#xD;
      unilateral leg DVT at time of enrollment, on duplex or other imaging study will be randomized&#xD;
      into two groups: the control group receiving the standard of care compression stockings and&#xD;
      the intervention group receiving ACTitouch device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    staffing change and lack of resources to conduct the study.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 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>subjects who meet the study entrance criteria will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the DVT has iliac or non-iliac involvement.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Villalta Score</measure>
    <time_frame>2 Years</time_frame>
    <description>The Villalta score is a disease score specific for PTS. It can be used to both diagnose and categorize the severity of the condition. It was developed in a cross-sectional study of 100 patients who were assessed 6 to 36 months after DVT.&#xD;
PTS not present: 0 to 4&#xD;
Mild PTS: 5 to 9&#xD;
Moderate PTS: 10 to 14&#xD;
Severe PTS: &gt;15</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Post Thrombotic Syndrome</condition>
  <condition>Deep Vein Thrombosis</condition>
  <arm_group>
    <arm_group_label>ACTitouch - ACT-Adaptive Compression Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a dual treatment pneumatic compression device offering two operational modes: sustained compression mode and intermittent compression mode. The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Compression Stocking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group will receive care using elastic compression stocking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACTitouch</intervention_name>
    <description>The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.</description>
    <arm_group_label>ACTitouch - ACT-Adaptive Compression Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compression garments (stockings)</intervention_name>
    <description>Compression garments (stockings) now serve as the generally recommended standard of care for patients post DVT and will be utilized as the control compression method in this study. Compression garments utilized in this study will be &quot;below the knee&quot; style with a pressure range of 30-40 mmHg. If a patient does not have compression garments as indicated, these stockings will be provided.</description>
    <arm_group_label>Standard Compression Stocking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age or older&#xD;
&#xD;
          -  History of an acute proximal unilateral leg DVT diagnosed one or more months prior to&#xD;
             enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of&#xD;
             enrollment, on duplex or other imaging study (i.e MRV, CTV, venogram)&#xD;
&#xD;
          -  Current anticoagulation therapy&#xD;
&#xD;
          -  Physical ability to independently don ACTitouch or availability of help to place&#xD;
             device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of PTS or PTS symptoms&#xD;
&#xD;
          -  Diagnosis of acute DVT less than 30 days prior to enrollment&#xD;
&#xD;
          -  History of prior ipsilateral DVT&#xD;
&#xD;
          -  Chronic venous insufficiency (CVI) with a CEAP 4 or greater and/or noted changes in&#xD;
             the deep system during the diagnosing duplex&#xD;
&#xD;
          -  Morbid Obesity (BMI &gt; 45)&#xD;
&#xD;
          -  Congestive heart failure with symptoms not controlled by medical intervention&#xD;
&#xD;
          -  Pulmonary edema, active, with symptoms not controlled by medical intervention&#xD;
&#xD;
          -  Peripheral artery disease (PAD) unless the patient has an ankle pressure of 60mmHg or&#xD;
             more&#xD;
&#xD;
          -  Walking disability (immobile)&#xD;
&#xD;
          -  Women who are pregnant or trying to become pregnant&#xD;
&#xD;
          -  Any other condition in which compression would be contraindicated as determined by the&#xD;
             treating physician&#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>Thomas Maldonado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adaptive Compression Therapy Delivery System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Postthrombotic Syndrome</mesh_term>
    <mesh_term>Postphlebitic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03039517
org study id: 15-01178
nct id: NCT03039517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a two arm, prospective, single center, randomized clinical trial. Subjects will be
      randomly assigned into one of two groups using block randomization technique in a 1:1 ratio.
      The control group will receive care using elastic compression stocking and the intervention
      group will use the ACTitouch device. Stratified randomization will occur based on whether the
      Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for
      2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.
The purpose of this study is to determine if use of a pneumatic compression device
      (ACTitouch, Tactile Medical) is beneficial in improving or preventing the development of Post
      Thrombotic Syndrome (PTS). 84 patients who have a history of an acute proximal unilateral leg
      DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal
      unilateral leg DVT at time of enrollment, on duplex or other imaging study will be randomized
      into two groups: the control group receiving the standard of care compression stockings and
      the intervention group receiving ACTitouch device.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: subjects who meet the study entrance criteria will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the DVT has iliac or non-iliac involvement.
primary purpose: Treatment
masking: None (Open Label)
measure: Villalta Score
time frame: 2 Years
description: The Villalta score is a disease score specific for PTS. It can be used to both diagnose and categorize the severity of the condition. It was developed in a cross-sectional study of 100 patients who were assessed 6 to 36 months after DVT.
PTS not present: 0 to 4
Mild PTS: 5 to 9
Moderate PTS: 10 to 14
Severe PTS: >15
arm group label: ACTitouch - ACT-Adaptive Compression Therapy
arm group type: Experimental
description: a dual treatment pneumatic compression device offering two operational modes: sustained compression mode and intermittent compression mode. The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.
arm group label: Standard Compression Stocking
arm group type: Experimental
description: The control group will receive care using elastic compression stocking.
intervention type: Device
intervention name: ACTitouch
description: The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.
arm group label: ACTitouch - ACT-Adaptive Compression Therapy
intervention type: Device
intervention name: Compression garments (stockings)
description: Compression garments (stockings) now serve as the generally recommended standard of care for patients post DVT and will be utilized as the control compression method in this study. Compression garments utilized in this study will be "below the knee" style with a pressure range of 30-40 mmHg. If a patient does not have compression garments as indicated, these stockings will be provided.
arm group label: Standard Compression Stocking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Maldonado, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Postthrombotic Syndrome
mesh term: Postphlebitic Syndrome
mesh term: Syndrome