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Criteria for Advanced Prosthetic Foot Prescription
NCT03505983 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.
Conditions Studied
Interventions
- DEVICE ESR Prosthetic Foot First
- DEVICE Articulating ESR Prosthetic Foot First
- DEVICE Powered Prosthetic Foot First
Study Locations (1)
New York
- VA New York Harbor Healthcare System — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03505983
The ClinicalTrials.gov registry entry for NCT03505983 describes a study currently listed as active not 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 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA New York Harbor Healthcare System, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Prosthesis User appearing as the primary indexed condition, and to 3 interventions — of which ESR Prosthetic Foot First 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: NCT03505983 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT03505983 about?
NCT03505983 is a clinical study titled "Criteria for Advanced Prosthetic Foot Prescription". The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returni...
What is the current status of trial NCT03505983?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 91 participants. The study started on 2018-03-07. Estimated completion is 2026-09-01.
What conditions does trial NCT03505983 study?
This clinical trial studies the following conditions: Prosthesis User, Amputation; Traumatic, Limb, Lower. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03505983?
The interventions under investigation include: ESR Prosthetic Foot First (DEVICE), Articulating ESR Prosthetic Foot First (DEVICE), Powered Prosthetic Foot First (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03505983?
This trial is sponsored by VA New York Harbor Healthcare System, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03505983 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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