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Moisture Management Liner Effectiveness Study

NCT04427007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-05-11

Study results available
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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.

Conditions

  • Amputation Stumps
  • Amputees
  • Amputation
  • Lower Limb Deformities, Congenital
  • Prosthesis User
  • Prosthesis

Interventions

DEVICE

Moisture Management Liner

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

DEVICE

Control Liner

The participant's usual prosthetic liner

Sponsors & Collaborators

  • Vivonics, Inc.

    collaborator INDUSTRY

  • Liberating Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-06-09
Completion
2022-01-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04427007 on ClinicalTrials.gov