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A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
NCT05473065 · View on ClinicalTrials.gov ↗
Study Summary
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.
Conditions Studied
Interventions
- DEVICE Multiaxial Prosthetic Foot Emulator
- DEVICE Commercially available prosthetic feet
Study Locations (2)
Minnesota
- Minneapolis VA Medical Center — Minneapolis
Washington
- VA Puget Sound Health Care System — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05473065
The ClinicalTrials.gov registry entry for NCT05473065 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 2 interventions — of which Multiaxial Prosthetic Foot Emulator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05473065 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05473065 about?
NCT05473065 is a clinical study titled "A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations". Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balanc...
What is the current status of trial NCT05473065?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-03-01. Estimated completion is 2026-07-31.
What conditions does trial NCT05473065 study?
This clinical trial studies the following conditions: Amputation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05473065?
The interventions under investigation include: Multiaxial Prosthetic Foot Emulator (DEVICE), Commercially available prosthetic feet (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05473065?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05473065 being conducted?
This trial has 2 study locations across Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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