Moisture Management Liner Effectiveness Study

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Prosthesis; Prosthesis User; Amputation Stumps; Amputees; Lower Limb Deformities, Congenital
• Intervention / Treatment: Device: Moisture Management Liner; Device: ICE Socket Cooling System

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Holliston, Massachusetts, United States, 01746
      • Liberating Technologies, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Prosthetic 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.	Device: Moisture Management Liner; A prototype liner designed to reduce and/or remove moisture and heat that builds up on the limb.; Device: ICE Socket Cooling System; The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.; Other Names: ICE System (Intrasocket Cooling Element); Active Cooling Socket
Other: Control Prosthetic Liner; 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.	Device: ICE Socket Cooling System; The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.; Other Names: ICE System (Intrasocket Cooling Element); Active Cooling Socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Limb Temperature	Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moisture Generation	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.	2 hours
Residual Limb Humidity	Changes in residual limb humidity during walking/resting measured with humidity sensors placed on the the limb.	2 hours
Liner/Socket Suspension	Changes in location of liner/socket on the residual limb during walking/resting measured by making marks on the limb with skin-safe markers.	2 hours
User Satisfaction	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).	2 hours

Collaborators and Investigators

• Sponsor: Liberating Technologies, Inc.
• Collaborators: Vivonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: thermal; Prosthesis; walking; heat; amputee; leg; cooling; perspiration; lower limb difference; socket; sweat; moisture; Prosthetic; Prosthetist; Liner; sock
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital
• Other Study ID Numbers: E00572.1a; 2020/01/1 (Other Identifier: Solutions IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No