At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Continuation of the Development of Moisture Management Liner and Active Cooling System for Improving Residual Limb Skin Care
In Brief
A clinical study evaluating ICE Condition and Sham Condition for Amputation and 5 related conditions. Completed, enrolled 12 participants across 2 sites.
Detailed 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. 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.
Study Details
Timeline
Interventions
Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.