Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II
2 other identifiers
observational
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 5, 2012
March 1, 2012
3 months
October 17, 2011
March 1, 2012
Conditions
Keywords
Study Arms (1)
Lower Limb Amputees
Those with lower limb amputations
Interventions
Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user
Eligibility Criteria
Subject will be selected from one prosthetic fabrication facility and recruited by their prosthetist
You may qualify if:
- lower limb amputation
- stable residual limb volume
- loss of limb due to trauma
- at least 18 years of age
You may not qualify if:
- evidence or history of neuropathy
- presence of phantom limb pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Infoscitex Corporationlead
- U.S. Army Medical Research and Development Commandcollaborator
- Mayo Cliniccollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Group Leader, Biomedical Devices
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 19, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 5, 2012
Record last verified: 2012-03