CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
Moisture Management Liner +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04427007
NCT04427007N/ACompleted

Moisture Management Liner Effectiveness Study

Liberating Technologies, Inc.·interventional·Posted Jun 11, 2020·Updated May 11, 2025

In Brief

A clinical study evaluating Moisture Management Liner and Control Liner for Amputation Stumps and 5 related conditions. Completed, enrolled 2 participants across 1 site.

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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsVivonics, Inc.

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartJul 1, 2020
Primary CompletionJun 9, 2021
Study CompletionJan 16, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.1 years ago

Interventions

Moisture Management Linerdevice

A prototype prosthetic liner designed to reduce and/or remove moisture and heat that builds up on the limb.

Control Linerdevice

The participant's usual prosthetic liner