NCT01309347

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

March 3, 2011

Last Update Submit

March 1, 2012

Conditions

Evaluation of a New Prosthetic Socket Liner Material.

Keywords

prosthetic socket, residual limb volume fluctuation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study will be conducted at one prosthetic fabrication facility.

You may qualify if:

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

You may not qualify if:

  • prosthetists who are not American Board for Certification of Orthotics and Prosthetics certified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Kristen LeRoy

    Infoscitex Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader, Biomedical Devices

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 2, 2012

Record last verified: 2012-03

Locations

US(1)