Moisture Management Liner Effectiveness Study

NCT04427007 | Completed Results FDA Device

• 2 other identifiers: E00572.1a2020/01/1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cooling; amputee; lower limb difference; Prosthetic; socket; Prosthesis; Prosthetist; Liner; sweat; walking; sock; leg; perspiration; moisture; heat; thermal

Outcome Measures

Primary Outcomes (1)

• Residual Limb Temperature

  Changes in residual limb temperature during walking/resting measured with temperature sensors placed on the limb. Positive values signify a raise in temperature and negative values signify a drop in temperature between the start of walking to the end of walking.

  2 hours

Study Arms (2)

Experimental Prosthetic Liner

EXPERIMENTAL

Participants will test the experimental prosthetic liner by walking on a treadmill while wearing the liner.

Device: Moisture Management Liner

Control Prosthetic Liner

OTHER

Participants will test the control (participant's usual) liner by walking on a treadmill while wearing the liner.

Device: Control Liner

Interventions

Moisture Management Liner DEVICE

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

Experimental Prosthetic Liner

Control Liner DEVICE

The participant's usual prosthetic liner

Control Prosthetic Liner

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower limb amputee
• Be willing and able to complete the tasks outlined
• Are at least 6 months on a definitive prosthesis
• Fits within an experimental liner
• Can understand English in order to be properly consented and provide their 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
• Other unforeseen disqualifying criteria (such as specific cognitive issues, etc.)

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead
• Vivonics, Inc.: collaborator

Study Sites (1)

Liberating Technologies, Inc.

Holliston, Massachusetts, 01746, United States

Location

MeSH Terms

Conditions

Lower Extremity Deformities, Congenital

Condition Hierarchy (Ancestors)

Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Brianna Rozell
• Organization: Liberating Technologies, Inc.

brianna.rozell@liberatingtech.com

774-233-0876

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: June 9, 2021
• Study Completion: January 16, 2022
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Locations

US (1)