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Moisture Management Liner At-Home Evaluation

NCT05124873 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-06-17

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 unbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment.

The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

Conditions

  • Amputation Stump
  • Amputation
  • Amputees
  • Lower Limb Deformity
  • Prosthesis User
  • Prosthesis

Interventions

DEVICE

Moisture Management Liner

A prototype liner designed to reduce heat that builds up on the limb.

Sponsors & Collaborators

  • Vivonics, Inc.

    collaborator INDUSTRY

  • Liberating Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2022-09-27
Completion
2022-09-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05124873 on ClinicalTrials.gov