Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II

The purpose of this study is to work with prosthetists to fit the novel conformable socket material developed by Infoscitex, to subjects, and determine if it is a viable alternative to current prosthetic socket liners. During this task, the research team will travel to the prosthetists locations to have them fit the subject with the conformable woven socket and a check socket, and provide subjective feedback with regard to comfort and fit for the amputee, its ease of use, and breathability. The subject will also wear the woven socket for gait analysis and provide his/her feedback as well.

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Key information

Conditions

Evaluation of a New Prosthetic Socket Liner Material

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Modern prosthetics have improved significantly with regards to control and functionality, but the fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. The volume of the residual limb of an amputee changes throughout the course of a day and throughout the year. Volume fluctuation within the socket can lead to issues for the amputee, including decreased comfort, increased shear forces, increased pressure on bony prominences, as well as a poor gait pattern. An uncomfortable or non-performing socket/residual limb interface decreases user compliance with the prosthetic and therefore decreases the activity level of amputees who want to remain active in their civilian and military lives. The investigators are developing a multilayered socket that takes advantage of a novel braided material for strength and passive conformability with thin layers dedicated to wearer comfort. This new socket provides ultimate fit for improvement in the performance of the prosthesis. The socket adapts itself to the changing physical shape of the residual limb as the prosthesis is worn. The adaptation is a natural result of the material properties, so is done passively and in real time. The materials are lightweight, breathable, and ultrasound transparent, allowing the prosthetic to function in a variety of environments.

This study will be undertaken to have prosthetists fit subject lower limb amputees with the woven inner socket, with a check socket for evaluation in a gait lab setting. At the completion, the subject and prosthetists will be asked to complete a questionnaire and give their opinions regarding the material of the woven inner socket.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

lower limb amputation
stable residual limb volume
loss of limb due to trauma
at least 18 years of age

Exclusion criteria

evidence or history of neuropathy
presence of phantom limb pain

Treatment and study plan

Novel conformable woven inner socket

Device

Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user

Sponsors and collaborators

Lead sponsor

Infoscitex Corporation

Industry

Collaborators

Mayo Clinic
U.S. Army Medical Research and Development Command

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Oct 19, 2011
Registry last updated: Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.