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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 7, 2011
Last Update Posted: March 2, 2012
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.
U.S. Army Medical Research and Materiel Command
Mayo Clinic
Information provided by (Responsible Party):
Kristen Leroy, Infoscitex Corporation
The purpose of this study is obtain prosthetist's feedback on the novel conformable socket material developed by Infoscitex, 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 evaluate the socket system by examining the material and providing their professional opinions and feedback with regard to comfort and fit for the amputee, its ease of use, and breathability.

Evaluation of a New Prosthetic Socket Liner Material.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional

Further study details as provided by Kristen Leroy, Infoscitex Corporation:

Enrollment: 6
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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 six prosthetists evaluate the material, where they will be asked to complete a questionnaire and give their opinions regarding the material. This will inform design changes for the material.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study will be conducted at one prosthetic fabrication facility.

Inclusion Criteria:

  • prosthetists who are active professionals and have clients (or have had clients in the past 6 months)

Exclusion Criteria:

  • prosthetists who are not American Board for Certification of Orthotics and Prosthetics certified
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01309347

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
Principal Investigator: Kristen LeRoy Infoscitex Corporation
  More Information

Responsible Party: Kristen Leroy, Group Leader, Biomedical Devices, Infoscitex Corporation
ClinicalTrials.gov Identifier: NCT01309347     History of Changes
Other Study ID Numbers: IST-1288 Study I
W81XWH-07-C-0094 ( Other Grant/Funding Number: US Army / TATRC )
First Submitted: March 3, 2011
First Posted: March 7, 2011
Last Update Posted: March 2, 2012
Last Verified: March 2012

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