Evaluation of a Novel Transfemoral Prosthetic Socket System
Prosthetic Socket System: Pilot Assessment
2 other identifiers
interventional
8
1 country
2
Brief Summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
2 active sites
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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJuly 1, 2013
June 1, 2013
1.5 years
May 1, 2013
June 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laser Doppler flowmetry tissue perfusion values
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month
1 month
Secondary Outcomes (6)
Laser speckle flowmetry tissue perfusion values
1 month
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)
1 month
Trans-Epidermal Water Loss values
1 month
Surface electrical capacitance values
1 month
Elasticity (cutometry) values
1 month
- +1 more secondary outcomes
Other Outcomes (2)
Skin temperature values
1 month
Prosthesis evaluation questionnaire (PEQ)
1 month
Study Arms (2)
Conventional TF Socket System
ACTIVE COMPARATORConventional Prosthetic Transfemoral Socket System
Novel TF Socket System
EXPERIMENTALNovel Prosthetic Transfemoral Socket System
Interventions
Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension
Eligibility Criteria
You may qualify if:
- Consenting Adult
- Unilateral transfemoral amputee
- Currently suing a liner with prosthesis
- Uses a prosthesis to ambulate
- Ability to read, write, and understand English
- Available during regular business hours for appointments
You may not qualify if:
- Impaired contra lateral leg
- Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
- Diagnosis of renal failure
- Smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio Willow Woodlead
- Ohio State Universitycollaborator
Study Sites (2)
The Ohio State University Davis Heart and Lung Research Institute
Columbus, Ohio, 43210, United States
The Ohio Willow Wood Company
Mount Sterling, Ohio, 43143, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gayle Gordillo, MD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
March 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
July 1, 2013
Record last verified: 2013-06