Status:
COMPLETED
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Lead Sponsor:
Ohio Willow Wood
Collaborating Sponsors:
United States Department of Defense
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
Detailed Description
Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees...
Eligibility Criteria
Inclusion
- Be a lower extremity amputee longer than one year
- Be a consenting adult (at least 18 years or age or older)
- Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
- Currently using a liner with prosthesis
- Be available during regular business hours for appointments
Exclusion
- An inability to give informed consent
- Presence of any sores, lacerations or rashes on the residual limb
- Impaired contra lateral foot
- Poor distal sensation
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01155024
Start Date
September 1 2010
End Date
September 1 2011
Last Update
January 11 2012
Active Locations (1)
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1
Ohio Willow Wood
Mount Sterling, Ohio, United States, 43143