<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/NCT04427007</url>
  </required_header>
  <id_info>
    <org_study_id>E00572.1a</org_study_id>
    <secondary_id>2020/01/1</secondary_id>
    <nct_id>NCT04427007</nct_id>
  </id_info>
  <brief_title>Moisture Management Liner Effectiveness Study</brief_title>
  <official_title>Moisture Management Liner Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liberating Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vivonics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Liberating Technologies, Inc.</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>
      The comfort and fit of the residual limb within a prosthetic socket are of primary concern&#xD;
      for many amputees. The residual limb is typically covered by non-breathable and non-&#xD;
      thermally conductive materials that can create a warm and ultimately moist environment.&#xD;
&#xD;
      The investigators have developed a silicone liner approach to remove sweat from the skin and&#xD;
      out of the socket and to passively conduct heat from the skin using thermally conductive&#xD;
      elastomers. This liner has been developed to work alongside a thermo-electric cooling&#xD;
      (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel&#xD;
      project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device can be embedded&#xD;
      into the prosthesis in order to cool the residual limb. A technology that can provide thermal&#xD;
      control while retaining adequate suspension, weight, and other prosthetic characteristics&#xD;
      would benefit many prosthesis wearers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The comfort and fit of the residual limb within a prosthetic socket are of primary concern&#xD;
      for many amputees. The residual limb is typically covered by non-breathable and non-&#xD;
      thermally conductive materials that can create a warm and ultimately moist environment. These&#xD;
      layers consist of a prosthetic liner that rolls onto the limb and traps heat and occasional&#xD;
      extra prosthetic socks. Studies found increases in socket temperature after the prosthesis&#xD;
      was donned. Temperatures were found to remain elevated long after activity cessation and even&#xD;
      a rest period of double the duration of the preceding activity period is insufficient to&#xD;
      return the limb to its initial temperature. A small amount of activity can cause the socket&#xD;
      temperature to elevate and remain at an uncomfortable level for an extended period of time,&#xD;
      which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb&#xD;
      interface decreases prosthesis use among amputees who want to remain active in their lives.&#xD;
&#xD;
      To address this, the investigators have developed a silicone liner approach to remove sweat&#xD;
      from the skin and out of the socket and to passively conduct heat from the skin using&#xD;
      thermally conductive elastomers. This liner has been developed to work alongside a&#xD;
      thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE)&#xD;
      developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE&#xD;
      device can be embedded into the prosthesis in order to cool the residual limb. A technology&#xD;
      that can provide thermal control while retaining adequate suspension, weight, and other&#xD;
      prosthetic characteristics would benefit many prosthesis wearers.&#xD;
&#xD;
      This study will focus on investigating the efficacy of this novel moisture and thermal&#xD;
      management (experimental) liner.&#xD;
&#xD;
      The rationale for this study is to determine how well the new technology can regulate the&#xD;
      residual limb temperature, reduce the moisture generation, and remove excess moisture in a&#xD;
      controlled laboratory environment.&#xD;
&#xD;
      The primary objective of this study is to measure the effects experimental techniques of&#xD;
      moisture and thermal management has on moisture and temperature in the socket. Moisture and&#xD;
      thermal management of the residual limb inside the prosthetic socket could result in greater&#xD;
      comfort while wearing the prosthesis, and ultimately could result in greater function and&#xD;
      better quality of life (QoL).&#xD;
&#xD;
      A repeated measures study will be conducted to analyze the temperature and moisture&#xD;
      generation of the residual limb with and without the experimental liner and active cooling&#xD;
      system within a standard prosthetic socket.&#xD;
&#xD;
      Both able-bodied research subjects, and lower limb amputee research subjects who use&#xD;
      transfemoral or transtibial prostheses will be recruited for testing. Liners for able-bodies&#xD;
      subjects will have the distal end removed to allow for donning. All subjects will visit&#xD;
      Liberating Technologies, Inc. to be consented and to complete study testing.&#xD;
&#xD;
      A maximum of 10 able-bodied and 20 lower-limb amputee subjects will be recruited for this&#xD;
      study. This is increased from a target 12 subjects to account for any drop-outs, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">January 16, 2022</completion_date>
  <primary_completion_date type="Actual">June 9, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual Limb Temperature</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moisture Generation</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in residual limb moisture generation during walking/resting measured by drying the participant's limb with a towel after walking. The towel and prosthetic liner will be weighed before and after walking to determine the amount of perspiration generated from walking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Limb Humidity</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in residual limb humidity during walking/resting measured with humidity sensors placed on the the limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liner/Socket Suspension</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in location of liner/socket on the residual limb during walking/resting measured by making marks on the limb with skin-safe markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Satisfaction</measure>
    <time_frame>2 hours</time_frame>
    <description>Surveys regarding user satisfaction while wearing and walking in the liner. A custom questionnaire using a 5 point Likert scale (1-5) will be used to rate different aspects of the control and experimental liner. Such as comfort (higher value is equal to a better outcome) and how much the participant perceives they sweat in the liner (lower value is equal to a better outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Amputation Stumps</condition>
  <condition>Amputees</condition>
  <condition>Amputation</condition>
  <condition>Lower Limb Deformities, Congenital</condition>
  <condition>Prosthesis User</condition>
  <condition>Prosthesis</condition>
  <arm_group>
    <arm_group_label>Experimental Prosthetic Liner</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will test the experimental liner in combination with the active cooling socket (ICE System). Prosthetic liners and socket will be tested by walking on a treadmill.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Prosthetic Liner</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will test the control liner in combination with the active cooling socket (ICE System). Prosthetic liners and socket will be tested by walking on a treadmill.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Moisture Management Liner</intervention_name>
    <description>A prototype liner designed to reduce and/or remove moisture and heat that builds up on the limb.</description>
    <arm_group_label>Experimental Prosthetic Liner</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ICE Socket Cooling System</intervention_name>
    <description>The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.</description>
    <arm_group_label>Control Prosthetic Liner</arm_group_label>
    <arm_group_label>Experimental Prosthetic Liner</arm_group_label>
    <other_name>ICE System (Intrasocket Cooling Element)</other_name>
    <other_name>Active Cooling Socket</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lower limb amputee&#xD;
&#xD;
          -  Be willing and able to complete the tasks outlined&#xD;
&#xD;
          -  Are at least 6 months on a definitive prosthesis&#xD;
&#xD;
          -  Fits within an experimental liner&#xD;
&#xD;
          -  Can understand English in order to be properly consented and provide their feedback to&#xD;
             the study personnel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The risks to pregnant women and fetuses are unknown and therefore pregnant women&#xD;
             should not participate in the study&#xD;
&#xD;
          -  Other unforeseen disqualifying criteria (such as specific cognitive issues, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Liberating Technologies, Inc.</name>
      <address>
        <city>Holliston</city>
        <state>Massachusetts</state>
        <zip>01746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Liberating Technologies, Inc.</investigator_affiliation>
    <investigator_full_name>Todd Farrell</investigator_full_name>
    <investigator_title>Director of Research</investigator_title>
  </responsible_party>
  <keyword>cooling</keyword>
  <keyword>amputee</keyword>
  <keyword>lower limb difference</keyword>
  <keyword>Prosthetic</keyword>
  <keyword>socket</keyword>
  <keyword>Prosthesis</keyword>
  <keyword>Prosthetist</keyword>
  <keyword>Liner</keyword>
  <keyword>sweat</keyword>
  <keyword>walking</keyword>
  <keyword>sock</keyword>
  <keyword>leg</keyword>
  <keyword>perspiration</keyword>
  <keyword>moisture</keyword>
  <keyword>heat</keyword>
  <keyword>thermal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Limb Deformities, Congenital</mesh_term>
    <mesh_term>Lower Extremity Deformities, Congenital</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/NCT04427007
org study id: E00572.1a
secondary id: 2020/01/1
nct id: NCT04427007
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The comfort and fit of the residual limb within a prosthetic socket are of primary concern
      for many amputees. The residual limb is typically covered by non-breathable and non-
      thermally conductive materials that can create a warm and ultimately moist environment.

      The investigators have developed a silicone liner approach to remove sweat from the skin and
      out of the socket and to passively conduct heat from the skin using thermally conductive
      elastomers. This liner has been developed to work alongside a thermo-electric cooling
      (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel
      project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device can be embedded
      into the prosthesis in order to cool the residual limb. A technology that can provide thermal
      control while retaining adequate suspension, weight, and other prosthetic characteristics
      would benefit many prosthesis wearers.
The comfort and fit of the residual limb within a prosthetic socket are of primary concern
      for many amputees. The residual limb is typically covered by non-breathable and non-
      thermally conductive materials that can create a warm and ultimately moist environment. These
      layers consist of a prosthetic liner that rolls onto the limb and traps heat and occasional
      extra prosthetic socks. Studies found increases in socket temperature after the prosthesis
      was donned. Temperatures were found to remain elevated long after activity cessation and even
      a rest period of double the duration of the preceding activity period is insufficient to
      return the limb to its initial temperature. A small amount of activity can cause the socket
      temperature to elevate and remain at an uncomfortable level for an extended period of time,
      which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb
      interface decreases prosthesis use among amputees who want to remain active in their lives.

      To address this, the investigators have developed a silicone liner approach to remove sweat
      from the skin and out of the socket and to passively conduct heat from the skin using
      thermally conductive elastomers. This liner has been developed to work alongside a
      thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE)
      developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE
      device can be embedded into the prosthesis in order to cool the residual limb. A technology
      that can provide thermal control while retaining adequate suspension, weight, and other
      prosthetic characteristics would benefit many prosthesis wearers.

      This study will focus on investigating the efficacy of this novel moisture and thermal
      management (experimental) liner.

      The rationale for this study is to determine how well the new technology can regulate the
      residual limb temperature, reduce the moisture generation, and remove excess moisture in a
      controlled laboratory environment.

      The primary objective of this study is to measure the effects experimental techniques of
      moisture and thermal management has on moisture and temperature in the socket. Moisture and
      thermal management of the residual limb inside the prosthetic socket could result in greater
      comfort while wearing the prosthesis, and ultimately could result in greater function and
      better quality of life (QoL).

      A repeated measures study will be conducted to analyze the temperature and moisture
      generation of the residual limb with and without the experimental liner and active cooling
      system within a standard prosthetic socket.

      Both able-bodied research subjects, and lower limb amputee research subjects who use
      transfemoral or transtibial prostheses will be recruited for testing. Liners for able-bodies
      subjects will have the distal end removed to allow for donning. All subjects will visit
      Liberating Technologies, Inc. to be consented and to complete study testing.

      A maximum of 10 able-bodied and 20 lower-limb amputee subjects will be recruited for this
      study. This is increased from a target 12 subjects to account for any drop-outs, etc.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Residual Limb Temperature
time frame: 2 hours
description: Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb.
measure: Moisture Generation
time frame: 2 hours
description: Changes in residual limb moisture generation during walking/resting measured by drying the participant's limb with a towel after walking. The towel and prosthetic liner will be weighed before and after walking to determine the amount of perspiration generated from walking.
measure: Residual Limb Humidity
time frame: 2 hours
description: Changes in residual limb humidity during walking/resting measured with humidity sensors placed on the the limb.
measure: Liner/Socket Suspension
time frame: 2 hours
description: Changes in location of liner/socket on the residual limb during walking/resting measured by making marks on the limb with skin-safe markers.
measure: User Satisfaction
time frame: 2 hours
description: Surveys regarding user satisfaction while wearing and walking in the liner. A custom questionnaire using a 5 point Likert scale (1-5) will be used to rate different aspects of the control and experimental liner. Such as comfort (higher value is equal to a better outcome) and how much the participant perceives they sweat in the liner (lower value is equal to a better outcome).
arm group label: Experimental Prosthetic Liner
arm group type: Experimental
description: Participants will test the experimental liner in combination with the active cooling socket (ICE System). Prosthetic liners and socket will be tested by walking on a treadmill.
arm group label: Control Prosthetic Liner
arm group type: Other
description: Participants will test the control liner in combination with the active cooling socket (ICE System). Prosthetic liners and socket will be tested by walking on a treadmill.
intervention type: Device
intervention name: Moisture Management Liner
description: A prototype liner designed to reduce and/or remove moisture and heat that builds up on the limb.
arm group label: Experimental Prosthetic Liner
intervention type: Device
intervention name: ICE Socket Cooling System
description: The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.
arm group label: Control Prosthetic Liner
arm group label: Experimental Prosthetic Liner
other name: ICE System (Intrasocket Cooling Element)
other name: Active Cooling Socket
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Liberating Technologies, Inc.
investigator full name: Todd Farrell
investigator title: Director of Research
mesh term: Limb Deformities, Congenital
mesh term: Lower Extremity Deformities, Congenital
sharing ipd: Undecided