Socket Cooling Effectiveness Take Home Study

Completed · Not applicable · Has a placebo group

Conditions studied: Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower, Prosthesis User, Lower Limb Amputation Below Knee (Injury)

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. To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that 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

NCT04484805

Run by

Liberating Technologies, Inc.

People needed

12

Starts

2019-08-01

Expected to finish

2020-11-03

Last updated by the study team

2024-10-22

Who can join

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

You may qualify if…

• Must have a lower limb absence
• Willing and able to complete outlined tasks
• Must complete and pass our Semmes-Weinstein monofilament test
• Must understand English in order to be properly consented and provide 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
• No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb

Where it is running

• Liberating Technologies, Inc. — Holliston, Massachusetts, United States
• Minneapolis VA — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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