Moisture Management Liner At-Home Evaluation

NCT05124873 | Terminated Results FDA Device

• 3 other identifiers: E00572.2a2020/09/1E00572.2b
• Study Type: interventional
• Target: 1
• 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 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Modified Dermatology Life Quality Index (mDLQI)

  The modified Dermatology Life Quality Index (mDLQI) is a modified version of the Dermatology Life Quality Index (DLQI). The DLQI is a simple questionnaire designed to measure the health-related quality of life of adult patients suffering from various skin diseases. A modified version of the questionnaire (mDLQI) was developed to be more directly applicable to persons with amputation (i.e., revised wording to apply to the skin on their residual limb). The modified survey is scored from 0 to 27, with lower numbers indicating a better outcome.

  4 weeks

Study Arms (1)

Experimental Prosthetic Liner

EXPERIMENTAL

Moisture Management Liner: A prototype liner designed to reduce heat that builds up on the limb. The participant wears this liner at home for about 4 weeks and provides feedback on the prototype.

Device: Moisture Management Liner

Interventions

Moisture Management Liner DEVICE

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

Experimental Prosthetic Liner

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• 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 lower-limb prosthesis
• Fits within an experimental liner (cushion style liner and size 23.5-28 cm)
• 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

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: November 18, 2021
• Study Start: May 12, 2021
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: June 17, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-06

Locations

US (1)