Moisture Management Liner Effectiveness Study

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04427007

Run by

Liberating Technologies, Inc.

People needed

2

Starts

2020-07-01

Expected to finish

2022-01-16

Last updated by the study team

2025-05-11

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

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

Full record on ClinicalTrials.gov

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