Moisture Management Liner Effectiveness Study
Phase: NA
Conditions: Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital, Prosthesis User, Prosthesis
Sponsor: Liberating Technologies, Inc.

 
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Moisture Management Liner Effectiveness Study 
Investigators 
Todd Farrell, PhD 
Liberating Technologies, Inc. 
325 Hopping Brook Road, Suite A 
Holliston, MA 01746 
(508) 893-6363 
 
Ryan Myers 
Vivonics, Inc. 
175 Great Road, Ste 110 
Bedford, MA 01730 
 
 
Sponsor 
U.S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY (USAMRAA) 
Sponsor Protocol # 
E00572.1a 
Solutions IRB # 
2020/01/01 
 
1.  Background and Introduction 
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 (0.8oC) [1] and after 30 
minutes of walking (2.5oC) [2].  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 
[3].  Peery, et al. [1] suggested that a modest temperature increase of only 2oC may be responsible for reports of thermal 
discomfort by amputees.  Therefore, 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, Vivonics, Inc. and Liberating Technologies, Inc. (LTI) have developed a silicone liner approach to wick sweat 
from the skin and out of the socket through specially designed microchannels 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 and LTI.  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. 
 

 
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2.  Study Rationale 
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. 
 
3.  Objectives 
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). 
 
4.  Study Design 
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.   
 
Test conditions include: 
- 
Control condition.  This would be a non-modified control liner (such as 
commercially off the shelf (COTS) liners or ones made without any additives) 
for able-bodied subjects and, for amputees, a check socket (with or without an 
unmodified control liner, depending on whether the amputee typically wears a 
liner or not).   
- 
Experimental liner condition.  This would be a prototype liner designed to 
reduce and/or remove moisture and heat that builds up on the limb. 
- 
Active cooling condition.  This would integrate the TEC module (see Figure 1) 
into the socket for amputees (with the experimental liner or with a control 
liner), or the TEC module with the experimental or control liner for able-bodied 
subjects.  
 
Passive cooling and moisture management will be achieved from an experimental liner 
made of standard silicone used in COTS liner with bio-compatible thermally conductive 
additives.  A standard check socket will be fabricated for each amputee subject if 
necessary to fit the experimental liner.  Additional modifications, such as channels in a 
liner and socket, may be used to remove moisture such as ones developed under New England IRB (NEIRB) protocol NEIRB 
# 14-232/HRPO Log A-17885. 
 
Active cooling will be achieved by embedding a TEC assembly into a standard prosthetic socket and liner.  The TEC assembly 
is comprised of a thermoelectric cooling unit (TEC), heat sink, fan and heat spreader and has previously been tested under 
New England IRB (NEIRB) protocol NEIRB # 120160413/HRPO Log A-17885.2. An experimental socket with the integrated 
heat spreader will be fabricated for each amputee subject.  The amputee subjects will either visit their prosthetist’s office 
Figure 1. TEC Module embedded into 
standard prosthetic socket for active 
cooling condition. 

 
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or LTI’s in-house prosthetist for measurements and the new socket will be fabricated. The subjects may return for 
alignment and adjustment on the new socket. 
 
Testing will measure the temperature, humidity, socket suspension and moisture accumulation of the limb when active 
cooling, moisture/thermal management, and no cooling is applied in order to determine the effectiveness of the proposed 
technology.   
 
Walking will be used to increase the temperature of the limb in order to measure the system’s ability to cool it as well as 
to determine subject perception of heat and comfort with the experimental liner and active cooling system as compared 
to the control liners and sockets. 
 
Research participants will have socket temperature and moisture data collected while walking on a treadmill in the 
different conditions throughout different site visits.  The active cooling from the ICE module will be completed with the 
experimental liner as well as with the control liner.  The order of conditions with the experimental and control liners and 
the active cooling on or off will be randomized for each subject. 
 
5.  Study Population 
Both able-bodied persons and persons with transfemoral and transtibial limb loss who are able to walk with a prosthesis 
will be recruited for this study.  Able-bodied subjects will be recruited via word of mouth.  LTI will enlist the aid of its 
current in-house prosthetist, Michael Amrich, CPO and its network of prosthetists including Next Step B&P, Cornell O&P, 
and several others, to assist in subject recruitment and will be given flyers to hand out to their patients.  Additionally, 
flyers will be distributed online (i.e. LTI’s website: LiberatingTech.com/research-studies) and in person by LTI to persons 
who may be within the target population.  If subjects are interested in participating, they can call the number on the flyer 
and schedule a time to discuss the study with the investigators.   
 
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. 
 
6.  Participant Eligibility 
Lower limb amputees will be identified who meet the following inclusion criteria: must be 18-89 years old, be willing and 
able to complete the tasks outlined, are at least 6 months on a definitive prosthesis, fits within an experimental liner, and 
can understand English in order to be properly consented and provide their feedback to the study personnel.  Subjects 
can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive 
issues, etc.). 
 
Subjects in this study will not be discriminated by sex or race. 
 
The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study 
and will be screened by self-disclosure. 
 
7.  Study Methodology 
Visit 1:  During the first visit, the subject will be consented and enrolled in the study.  Measurements and molds will be 
taken of the residual limb so an experimental socket can be fabricated.  For the purposes of this study, the prosthetic liner 
is being standardized and all subjects will be provided with a prosthetic liner of the proper size, such as an Iceross Comfort 
Liner by Ossur or the Superior Performance Liner by ALPS, that has been deemed appropriate by a certified prosthetist 

 
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and matches the thickness of the experimental liner.  Similarly, if a subject typically uses prosthetic socks, they will be 
provided with a standardized gel sock instead, such as the Silosheath gel sock by Silipos, of the proper size that has been 
deemed appropriate by a certified prosthetist. 
 
The experimental liner will be tested on the subject to ensure proper fit and comfort as determined by a certified 
prosthetist.  The subject may be asked to wear the liner without a prosthesis while at home before the second visit to 
acclimate to the liner(s) as is standard care.  During this visit the subject will be asked to completed standard 
questionnaires regarding their quality of life with their current liner.  These will include questionnaires commonly used 
such as the Dermatology Life Quality Index [4,5], the Residual Limb Health section of the Prosthesis Evaluation 
Questionnaire (PEQ) [6], and the EuroQol-5D. 
 
The experimental socket would be created to fit the subject while wearing the gel sock (if applicable) and appropriate liner 
using standard clinical socket fabrication techniques.  As part of the standard of care when fabricating a new prosthetic 
socket, the prosthetist first creates a check socket with which to test the fit on the subject before fabricating the definitive 
socket.  Check sockets are structurally sound to walk on and use but may be a littler bulkier and heavier than a definitive 
socket.  Because all testing will be completed in-lab, the check socket will be used for all research activities.  LTI will 
fabricate the prosthetic sockets and install the ICE units in them. 
 
At the same time the prosthetist fabricates the socket, s/he may also create a clear, limb “template” similar to the check 
socket that matches the limb without accommodating any liner or socks (skin fit).  This template allows the location of the 
sensors on the limb to be marked on the template so that the sensors can be placed in the same location on the limb for 
each lab test visit.   
 
This visit will take up to 2 hours. 
 
Visit 2:  When the experimental socket has been fabricated and instrumented, the subject will return to the lab for a 
second visit.  The subject will be asked to meet with the prosthetist to try on the check socket for fit and alignment with 
the control and experimental liners.  
 
The subject will then perform in-laboratory testing to determine the effectiveness of an experimental liner to keep the 
limb cooler and dryer as compared to the control prosthetic liner.  The order of conditions (Experimental Liner versus 
Control Liner, with or without the active cooling ICE unit) will be randomized.   
 
Similar to what was done in a prior protocol under a previous effort (NEIRB # 120160413/HRPO Log A-17885.2), an array 
of temperature sensors will be attached to the subject’s residual limb before donning the socket and/or liner to give a 
more complete picture of the overall temperature distribution across the residual limb.  Baseline readings will be taken of 
the residual limb temperature, the body’s core temperature via an oral thermometer, and the ambient temperature. 
   
In addition, we will measure the amount of perspiration produced during each condition.  The limb will be dried with a 
towel, so pre- and post-activity weight of the liner and towel will be measured and the difference in weight is attributed 
to the sweat produced during that condition as described by Wernke et al. [7].  Testing may also be performed in a thermal 
chamber that regulates the temperature of the testing area, such as that used by Klute et al. [8], to ensure that the subject 
will perspire. 
 

 
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In addition, humidity sensors will be attached to the subject’s residual limb before donning the socket and/or liner similar 
to work completed by Cutti et al. [9].  These will allow a more complete picture of the onset of moisture on the residual 
limb during activity. 
 
In addition, marks will be made with a skin safe marker on the leg where the top of liner rests before the subject begins 
the testing activity (such as walking on a treadmill). Once the testing activity has ended, the same mark will be made on 
the leg where the top of the liner rests. The distance between these lines will show any slippage that occurred during the 
activity which may be due to a lack of suspension. 
 
The subject will be asked to do the following tasks, similar to Klute et al. [3]:  (1) an initial seated rest for up to 60 minutes 
to obtain baseline in-socket temperature data; (2) an activity to increase their body temperature, such as walking on a 
treadmill [2, 3] for up to 30 minutes; (3) a seated rest for up to 60 minutes; and (4) the liner and perspiration will be 
collected off the limb (with a towel) and weighed for changes.  The second condition will begin once baseline temperatures 
have been reached and the test procedure repeated in the other condition 
 
Throughout the in-lab test sessions, photos and/or videos may be taken to document such things as the location of the 
sensors on the limb, the temperature gradients across the limb (with a thermal camera), etc.  At the end of each condition, 
subjective feedback on the comfort and temperature regulation of each condition will be obtained via a questionnaire 
developed during this effort.  The participants would fill out the questionnaire rating parameters such as perceived 
comfort, intra-socket temperature, potential loss of suspension, etc. 
 
This visit will take up to 4 hours. 
 
This visit can be repeated at the subject’s volition, if more data is required or if re-testing is needed. 
 
Visit 3:  The same tasks as described in Visit 2 will be completed using the same data collection process.  The order of 
conditions (Experimental Liner versus Control Liner, with or without the active cooling ICE unit) will be randomized.  The 
subject will perform in-laboratory testing to determine the effectiveness the ICE unit to cool and reduce moisture 
generation of a residual limb with an experimental liner as compared to with a standard control prosthetic liner.   
 
We expect to demonstrate that even if the socket doesn’t reduce the temperature during walking, it can cool the socket 
immediately upon cessation of walking, unlike the standard socket that produces the sustained high temperatures 
observed by Klute, et al. [3] and Huff, et al. [2].  This benefit is expected to increase with the addition of the experimental 
thermally conductive liner. 
 
This visit will take up to 4 hours. 
 
This visit can be repeated at the subject’s volition, if more data is required or if re-testing is needed. 
 
Once all testing is completed, the research participant will complete a questionnaire to describe their opinions on the 
comfort, look, and functionality of the experimental liner and ICE unit.  
 
8.  Study Conduct 
Subjects will be consented and screened for eligibility criteria.  If they decide to participate, an experimental liner will be 
made that fits the size and shape of their limb and an experimental socket to fit the experimental liner will be fabricated 
using standard prosthetic techniques. 

 
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Subjects may withdraw at any time by simply telling the investigators they wish to stop their participation. 
 
If a subject withdraws from the study, the data that were collected from them can still be used, and the withdrawn subjects 
may be replaced with a new subject.  Deviations from the protocol that increase risks for subjects will be reported to 
Solutions IRB and HRPO for approval prior to being implemented. 
 
The consent process and all testing will be completed at the Liberating Technologies, Inc. research facility located in 
Holliston, MA. Approved study staff from Vivonics, Inc. may also be present during testing visits to provide technical 
support or monitor testing activities. During these visits approved study staff from Vivonics, Inc. may be in contact with 
the subjects. 
 
Subjects will be compensated $40 per hour for the 3 visits for the in-lab testing and prosthetist visits for an estimated total 
of $400 (10 hours) per subject.  Travel will also be reimbursed per mile at the current IRS federal rate. 
 
9.  Study Treatment 
This is not a treatment study.  The purpose of the study is to evaluate the effectiveness of a moisture removal and 
thermally conductive liner.   
 
10.  Evaluation of Adverse Events 
Based on past testing and data collection, no adverse events are expected.  Adverse events could include: discomfort or 
dermatological reaction to experimental liner materials or sensors in the socket, tripping while walking on the treadmill, 
overheating or overcooling due to controller, sensor, or battery malfunction of the ICE unit.  These risks have been 
mitigated by using biocompatible materials and/or hypoallergenic tape with the sensors, using a spotter during walking 
tasks for in-lab testing, and standard thermal and electrical management techniques including thermal battery 
management, voltage/current limiting, and monitoring temperature during testing. 
 
All unanticipated problems involving risk to subjects or others, serious adverse events related to participation in the study 
and subject deaths related to participation in the study will be promptly reported to the Solutions IRB and HRPO.  A written 
description of the adverse event will be stored in the study file maintained by the Principal Investigator.  Also, the protocol 
will be reviewed in light of the adverse event to determine if modifications need to be made to prevent the event from 
occurring again.  Major modifications to the research protocol and any modifications that could potentially increase risk 
to human subjects must be submitted to the Solutions IRB and HRPO for approval prior to implementation. 
 
11.  Ethical Considerations 
There is no direct benefit to the user.  Participating in this study may potentially advance the scientific community’s 
understanding on the ability of reducing intra-socket moisture generation and cooling intra-socket temperatures to 
improve comfort and quality of life for lower limb amputees.   
 
The protocol, consent form, and recruitment flyer will require IRB review and approval.  The principal investigator will be 
in continuous communication with the IRBs and HRPO and will forward information to the co-investigators.  Subjects’ 
participation is voluntary, and they may withdraw from participation in the study at any time by simply telling any one of 
the investigators that they wish to stop.  The investigators may choose to terminate a subject’s participation if he or she 
experiences discomfort or injury.  In addition, participants will be given any new information which is discovered during 
the course of the study which may influence participants’ willingness to continue the study.  If they desire to do so, 

 
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subjects’ will also have the option to discuss any concerns regarding the study activities or the investigators with an 
impartial staff member of the site IRB, whose duty it is to hear and review such concerns and provide advice or take any 
other appropriate actions. 
 
The investigators will ensure the anonymity of all participants in this study.  After completing the consenting process, 
subjects will be assigned a random identification number.  The number will be used on all test data associated with the 
subject.  No personal identifiers will be associated with the data collected from the subjects during the various tests.  The 
PI will have a master document linking the subject name with ID number, and it will be stored on a password protected 
computer, with only the PI and approved study staff having access to the master list.  All collected test data will be kept 
at Liberating Technologies, Inc. and stored in a secure manner depending on the media: either a password protected 
computer with access limited to the co-investigators, or in a locked filing cabinet in the investigator’s office.  A copy of the 
test data will also be retained by the PI in the program folder, also stored in a secured manner. Deidentified test data may 
also be stored at Vivonics, Inc. using the random identification numbers assigned to subjects.  
 
12.  Study Monitoring and Oversight 
The oversight of the study falls on the PI and co-investigators.  They will be responsible for ensuring the study follows the 
approved protocol and for reporting any deviations or adverse events that occur during the study to Solutions IRB and 
HRPO.  De-identified data, photos, and videos will be kept indefinitely to show in scientific presentations and publications.  
Photos will not contain any identifying information about the subject.  The photographs will not include the subject’s face 
or any identifying marks such as tattoos.  If identifying photographs happen to be received from a subject, they will be de-
identified by either cropping or blurring using photo-editing software. 
 
Additionally, representatives of the United States Army Medical Research Acquisition Activity (USAMRAA) are eligible to 
review research records as a function of their responsibility to protect subjects in research. 
 
13.  Investigational Product Management 
The experimental liners tested in this study are modified to increase the thermal conductivity and remove moisture from 
the limb to regulate intra-socket temperature and reduce moisture accumulation.  The ICE technology tested in this study 
is a cooling device for the residual limb that is an add-on system to a standard prosthetic socket.  Additionally, 
commercially-available temperature and humidity sensors may also be used in the instrumented sockets. 
 
EXPERIMENTAL LINER 
The experimental liner is a product of mixing thermally conductive additive to a base silicone material. The base material 
is a medical grade room temperature curing silicone rubber (RTV-2) from Wacker Chemie AG with characteristics of 
biocompatibility, low surface tension, thermal and chemical stability. This silicone can be sterilized easily for single as well 
as repeated use. The nature of the silicone is hydrophobic which prevents microbial growth. Additives such as boron 
nitride, carbon and graphene nanoparticles are added to enhance the thermal conductivity of the liner. These 
nanomaterials are skin safe and are currently being used in other skin contacting applications such as cosmetics and 
wearable electronics [10, 11, 12, 13].  
The experimental liner will be manufactured and packaged at a manufacturing facility that makes COTS liners using the 
standard procedures. 
 
INTRASOCKET COOLING ELEMENT 
The ICE active cooling module is comprised of a combination of: 1) an inner Heat Spreader (isothermal) layer designed to 
maintain approximately constant temperature along a section of the inner wall of the socket and 2) a Heat Extractor 

 
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providing a heat channeling pathway utilizing: a) a Thermo-Electric Cooling (TEC) module, b) a heat radiator (heat sink) 
structure and c) an air circulating system (fan) to discharge the heat to the surrounding air.   
 
The heat spreader functions to collect heat from around the circumference of the limb and then route it to a much smaller 
and more focal point where it is expelled from the socket by the heat extractor.  Additionally, the system has been 
developed to work in conjunction with commercially-available prosthetic liners where the heat spreader is in contact with 
the liner, not the skin, and pulls the excess heat through the liner to extract it. 
 
The active heat pumping mechanism that is used in these devices is a thermoelectric cooler (TEC).  TECs are semiconductor 
devices that use electrical current to pump heat from one side of the device to the other based on the Peltier effect.  As 
an active system, a TEC can chill the heat source (residual limb) to a temperature lower than its surroundings.  In the ICE 
system, the TEC is used to pump heat from the heat spreader to a heat sink acting as a radiator.  The TEC raises the heat 
sink to a temperature above ambient.  A fan then facilitates removal of heat from the heat sink.  The TEC heat pumping 
action is particularly useful in high ambient temperature situations where the heat sink and fan alone would not be able 
to sufficiently cool the hot side of the heat spreader. 
 
The ICE unit is powered by a standard, commercially-available 2 cell Li-ion rechargeable battery pack, such as the Tenergy 
18650 7.2V 3500mAh battery, and is housed in a case to protect against damage.  This battery has protection circuitry, 
including over-charge, over-discharge and short-circuit protection, and is being charged with the recommended charger 
externally, off the subjects.  Control of the device is based on a push button where the user engages the button when 
he/she feels that cooling in necessary and turns off the system when he/she no longer needs cooling.    When the device 
is on, the system will to regulate cooling to the limb based on feedback from multiple sensors in the device, including the 
hot and cold side temperatures of the TEC.  As long as the cold side of the TEC is above the minimum threshold, the TEC 
will be powered to reduce the limb temperature while taking into account battery life.  As the cold side temperature 
approaches the threshold temperature, the voltage to the TEC will be reduced to maintain a TEC cold side temperature 
above the threshold.  Prior studies have shown that applying cooling at a temperature of 22oC (72oF) is the lowest 
temperature that is uniformly well-tolerated [5].  Because we will have a prosthetic liner between the ICE cooling element 
and the skin, we will use a cold side threshold temperature that takes into account the thermal properties of the 
standardized liner to ensure a residual limb temperature of no less than 22oC.  Our testing has shown that the cold side 
threshold can be as low as 11.5oC (53oF) and still maintain a skin temperature of greater than 22oC.  Therefore, based on 
this data, we will use 11.5oC as our minimum cold side temperature threshold; however, we may iterate the control 
algorithm and adjust the threshold as needed as more data is collected that can inform the algorithm.   
 
SOCKETS 
The prosthetic interface used in this study will be fabricated by a Board-Certified Prosthetist, following conventional 
standardized methods.  The “ICE System” is to be incorporated into the socket design with manufacturing techniques 
similar to those used to integrate commercially-available prosthetic components and add-ons, such as suction valves, 
shuttle locks, elevated vacuum systems (e.g.  Ohio Willow Wood ONE system), etc and used in a prior approved protocol 
(NEIRB # 120160413/ HRPO Log A-17885.2).  The inclusion of the “ICE System” will be such that the structural integrity 
and functionality of the socket will not be compromised.  The socket characteristics will be similar to the subject’s usual 
socket, monitoring and maintaining acceptable mobility and comfort throughout the testing procedure.   
 
CONTROL LINERS 
The control liners tested in this study will either be commercial-off-the-shelf (COTS) products that are approved for the 
general population or made with only the base silicone of the experimental liners.  We have standardized the control liner 
used for this study in order to eliminate confounding factors of liner material and thickness.   

 
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PROSTHETIC SOCKS 
The prosthetic socks in this study will be commercial-off-the-shelf (COTS) products that have been identified to work well 
with the ICE system, for example, the Silosheath gel sock by Silipose. 
 
TEMPERATURE SENSORS 
Commercially available temperature sensors, such as thermistors, thermocouples and iButtons, may be used to monitor 
the temperature of the ICE device as well as the temperature of the residual limb inside the prosthetic socket.  The 
thermistors and thermocouples have been used in the approved protocols for the previous and current studies (NEIRB # 
120160413/ HRPO Log A-17885.2).  The iButton has been used in O&P clinical practice and research studies to monitor 
temperatures within O&P devices [15]. 
 
HUMIDITY SENSORS 
Commercially available humidity sensors, such Sensirion SHT21S, may be used to monitor the humidity of the residual 
limb inside the prosthetic socket.  This humidity sensor has been used in another research study on prosthetic sockets 
following a similar protocol by Cutti et al. [9]. 
 
14.  Data Analysis 
The data collected in the laboratory will include limb temperature, ambient temperature, limb humidity, ambient 
humidity, and moisture generation on the limb.  Standard outcomes measures will include:  Dermatology Life Quality 
Index, Modified Dermatology Life Quality Index, the Residual Limb Health section of the Prosthesis Evaluation 
Questionnaire (PEQ), and the EuroQol-5D).  Custom questionnaires that were developed to assess the experimental liner 
and ICE system will also be used.   
 
The primary outcome of this study will assess the effect of the experimental liners on the temperature of the residual 
limb; however secondary measures include moisture generation and humidity on the residual limb as well as satisfaction 
with the prosthesis using the above measures.  Measures during the experimental liner conditions will be compared to 
the control conditions both with and without the ICE system being active. 
 
15.  References 
 
[1] J. T. Peery, W. R. Ledoux, and G. K. Klute, “Residual-limb skin temperature in transtibial sockets,” The Journal of 
Rehabilitation Research and Development, vol. 42, no. 2, pp. 147–154, 2005. 
[2] E. A. Huff, W. R. Ledoux, J. S. Berge, and G. K. Klute, “Measuring Residual Limb Skin Temperatures at the Skin-
Prosthesis Interface,” JPO Journal of Prosthetics and Orthotics, vol. 20, no. 4, pp. 170–173, Oct. 2008. 
[3] G. K. Klute, E. Huff, and W. R. Ledoux, “Does Activity Affect Residual Limb Skin Temperatures?,” Clinical Orthopaedics 
and Related Research®, vol. 472, no. 10, pp. 3062–3067, Jun. 2014. 
[4] A. Finlay and G. Khan, “Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use,” 
Clinical and Experimental Dermatology, vol. 19, no. 3, pp. 210–216, 1994. 
[5] H. Meulenbelt, J. Geertzen, M. Jonkman, and P. Dijkstra, “Skin Problems of the Stump in Lower-limb Amputees: 2. 
Influence on Functioning in Daily Life,” Acta Dermato Venereologica, vol. 91, no. 2, pp. 178–182, 2011. 
[6] D. A. Boone and K. L. Coleman, “Use of the Prosthesis Evaluation Questionnaire (PEQ),” JPO Journal of Prosthetics 
and Orthotics, vol. 18, no. Proceedings, 2006. 

 
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[7] M. M. Wernke, R. M. Schroeder, C. T. Kelley, J. A. Denune, and J. M. Colvin, “SmartTemp Prosthetic Liner Significantly 
Reduces Residual Limb Temperature and Perspiration,” Journal of Prosthetics and Orthotics, vol. 27, no. 4, pp. 
134–139, Oct. 2015. 
[8] G. K. Klute, J. S. Berge, and C. undefined King, “Perspiration and Secure Suspension for Lower Limb Amputees in 
Demanding Environments,” in American Academy of Orthotists & Prosthetists 43rd Academy Annual Meeting & 
Scientific Symposium Journal of Proceedings, 2017. 
[9] A. Cutti, P. Perego, M. Fusca, R. Sacchetti, and G. Andreoni, “Assessment of Lower Limb Prosthesis through Wearable 
Sensors and Thermography,” Sensors, vol. 14, no. 3, pp. 5041–5055, Mar. 2014. 
[10] Song Y, Huang W, Mu C, et al. Carbon Nanotube‐Modified Fabric for Wearable Smart Electronic‐skin with Exclusive 
Normal‐Tangential Force Sensing Ability. Advanced Materials Technologies. 2019;4(5):N.PAG. 
[11] Son D, Koo JH, Song J-K, et al. Stretchable carbon nanotube charge-trap floating-gate memory and logic devices for 
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[12] Türkez H, Arslan ME, Sönmez E, Açikyildiz M, Tatar A, Geyikoğlu F. Synthesis, characterization and cytotoxicity of 
boron nitride nanoparticles: emphasis on toxicogenomics. Cytotechnology. 2019;71(1):351. 
[13] Fiume MM, Bergfeld WF, Belsito DV, et al. Safety Assessment of Boron Nitride as Used in Cosmetics. International 
Journal Of Toxicology. 2015;34(3 Suppl):53S-60S. 
[14] A. Bandla, R. Sundar, L.-D. Liao, S. S. H. Tan, S.-C. Lee, N. V. Thakor, and E. P. V. Wilder-Smith, “Hypothermia for 
preventing chemotherapy-induced neuropathy – a pilot study on safety and tolerability in healthy controls,” 
Acta Oncologica, vol. 55, no. 4, pp. 430–436, Sep. 2015. 
[15] K. M. Felton, S. Savage, and L. Karol, “Patient Adherence to Instructions of Weaning into Scoliosis Orthosis Wear,” 
Journal of Prosthetics and Orthotics, vol. 27, no. 1, pp. 23–26, Jan. 2015.

 
 
APPENDIX A – QUESTIONNAIRES EXPLANATION 
 
Surveys and Questionnaires 
During the human subjects testing we will be collecting subjective feedback on the comfort and temperature of the 
experimental liner as well as quality of life with their current liner. These will include the Dermatology Life Quality Index, 
the Residual Limb Health section of the Prosthesis Evaluation Questionnaire (PEQ), the EuroQol-5D, and custom 
questionnaires specific to the experimental liner. Some will be administered before any testing, such as the quality of life 
surveys regarding their current liner, others will be administered immediately upon the conclusion of each test session 
such as the custom questionnaires. 
Visit #1 – Part #1 – Dermatology Life Quality Index 
The Dermatology Life Quality Index (DLQI) is a simple, self-administered, validated questionnaire developed by Finlay 
and Khan [1] that is designed to measure the health-related quality of life of patients suffering from skin issues. 
Visit #1 – Part #2 – Modified Dermatology Life Quality Index 
Meulenbelt et. al. [2] has modified the DLQI (mDLQI) to apply on a monthly basis and applied it to amputees. The results 
of this questionnaire will be compared to the validated DLQI. The questionnaire was modified slightly from Meulenbelt 
et al. for grammatical errors and to change “amputation stump” to “residual limb” to use more commonly accepted 
terminology. 
Visit #1 – Part #3 – EuroQoL-5D 
Another questionnaire we will be using is the EuroQoL-5D (EQ-5D) survey. The EQ-5D is a well-known and widely used 
health status instrument that was developed by the EuroQol Group and has remained fundamentally unchanged since it 
was introduced in the 1990s.  The number of studies using the EQ-5D suite of instruments, registered with the EuroQol 
Group, totaled over 17,000 by 2015. EQ-5D is designed for self-completion by respondents and is ideally suited for use in 
surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding and takes only a few minutes to 
complete.  We will be using the EQ-5D as a validated measure of quality of life. 
Visit #1 – Part #4 – Residual Limb Health Scale 
The fourth measure we will be using is a subscale of the validated Prosthesis Evaluation Questionnaire (PEQ) [3]. The 
PEQ consists of 82 items grouped into nine subscales, each addressing a different aspect of prosthesis wear (pain, 
satisfaction, comfort, etc.).  The PEQ scales are not dependent on each other, so it is reasonable to use only those scales 
of interest. We will be using the Residual Limb Health section which rates qualities such as in-socket perspiration and 
skin breakdown of the residual limb. For each scale used, all of the individual questions that make up that scale must be 
included. The questions refer to the prior 4 weeks and are scored using a visual analog scale (100mm line). There is no 
total score. A guide gives coding instructions for all questions and groups the questions under different subscales. Each 
subscale score is computed by excluding any unanswered questions and averaging the answers within each subscale.  
Visit #2 & Visit #3 – Part #1 & Part #2 – Individual Liner Questionnaire 
The custom individual liner questionnaire was developed to rate the different aspects of the experimental and control 
liner. This questionnaire will be completed immediately after each activity to rate the liner that was used during that 
activity. 
Visit #2 & Visit #3 – Part #3 – Liner Comparison Questionnaire 
The custom liner comparison questionnaire was developed to measure the subject’s preference for different criteria 
between the experimental and standard liner. This questionnaire will be completed at the end of Visit #2 and Visit #3 
after the subject has completed both sets of activities. 
 
 

 
 
References 
[1] A. Finlay and G. Khan, “Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use,” 
Clinical and Experimental Dermatology, vol. 19, no. 3, pp. 210–216, 1994. 
[2] H. Meulenbelt, J. Geertzen, M. Jonkman, and P. Dijkstra, “Skin Problems of the Stump in Lower-limb Amputees: 2. 
Influence on Functioning in Daily Life,” Acta Dermato Venereologica, vol. 91, no. 2, pp. 178–182, 2011. 
[3] D. A. Boone and K. L. Coleman, “Use of the Prosthesis Evaluation Questionnaire (PEQ),” JPO Journal of Prosthetics 
and Orthotics, vol. 18, no. Proceedings, 2006. 

 
 
APPENDIX B – QUESTIONNAIRES