Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04427007 |
| Other study ID # |
E00572.1a |
| Secondary ID |
2020/01/1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
January 16, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Liberating Technologies, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
