Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
(SocketFit Trial)
AG
Overseen ByAlena Grabowski, PhD BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial is testing a new type of adjustable prosthetic socket to see if it improves comfort and function for veterans with lower limb amputations compared to regular sockets. The iFIT transtibial prosthetic system has shown promising results in previous studies, indicating improved comfort and lower intrasocket peak pressures compared to conventional prostheses.
Research Team
AG
Alena Grabowski, PhD BA
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Eligibility Criteria
Inclusion Criteria
You are 20 or older and have a unilateral transtibial amputation.
A maximum of 40 Veterans will be recruited.
All participants must have a fully functional prosthesis and be at least 6-months post-amputation with no current issues regarding their residual limb.
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Treatment Details
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Veterans with a transtibial amputationExperimental Treatment2 Interventions
20 Veterans with a transtibial amputation, 10 females and 10 males
Group II: Veterans with a transfemoral amputationExperimental Treatment2 Interventions
20 Veterans with a transfemoral amputation, 10 females and 10 males
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Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Trials
1,691
Recruited
3,759,000+
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