Moisture Management Liner Effectiveness Study

Not Applicable

Completed

Conditions: Amputation Stumps
Prosthesis
Amputees
Lower Limb Deformities, Congenital
Amputation
Prosthesis User

Interventions: Device: Moisture Management Liner
Device: ICE Socket Cooling System

Registration Number: NCT04427007

Lead Sponsor: Liberating Technologies, Inc.

Brief 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 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). Other measures that may be collected are exploratory.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2

Inclusion Criteria

Lower limb amputee
Be willing and able to complete the tasks outlined
Are at least 6 months on a definitive prosthesis
Fits within an experimental liner
Can understand English in order to be properly consented and provide their feedback to the study personnel

Exclusion Criteria

The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
Other unforeseen disqualifying criteria (such as specific cognitive issues, etc.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Prosthetic Liner	ICE Socket Cooling System	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.
Control Prosthetic Liner	ICE Socket Cooling System	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.
Experimental Prosthetic Liner	Moisture Management Liner	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.

Primary Outcome Measures

Name	Time	Method
Residual Limb Temperature	2 hours	Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb. Positive values signify a raise in temperature and negative values signify a drop in temperature between the start of walking to the end of walking.

Secondary Outcome Measures