Moisture Management Liner Effectiveness Study
Condition: Amputation Stumps; Amputees; Amputation; Lower Limb Deformities, Congenital; Prosthesis User; Prosthesis
MeSH terms: Limb Deformities, Congenital; Lower Extremity Deformities, Congenital
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Moisture Management Liner; ICE Socket Cooling System
Intervention type(s): Device; Device
Intervention description(s): A prototype liner designed to reduce and/or remove moisture and heat that builds up on the limb.; The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.
Other intervention name(s): ICE System (Intrasocket Cooling Element); Active Cooling Socket
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cooling; amputee; lower limb difference; Prosthetic; socket; Prosthesis; Prosthetist; Liner; sweat; walking; sock; leg; perspiration; moisture; heat; thermal