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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455324
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : March 5, 2012
U.S. Army Medical Research and Materiel Command
Mayo Clinic
Information provided by (Responsible Party):
Kristen Leroy, Infoscitex Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Evaluation of a New Prosthetic Socket Liner Material Device: Novel conformable woven inner socket

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Group/Cohort Intervention/treatment
Lower Limb Amputees
Those with lower limb amputations
Device: Novel conformable woven inner socket
Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject will be selected from one prosthetic fabrication facility and recruited by their prosthetist

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455324

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Infoscitex Corporation
U.S. Army Medical Research and Materiel Command
Mayo Clinic

Responsible Party: Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation Identifier: NCT01455324     History of Changes
Other Study ID Numbers: IST1288 Study 2
W81XWH-07-C-0094 ( Other Grant/Funding Number: US Army MRMC )
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Kristen Leroy, Infoscitex Corporation:
prosthetic socket
residual limb volume fluctuation
conformable socket liner