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NCT03505983 · ClinicalTrials.gov registry record · NA

Criteria for Advanced Prosthetic Foot Prescription

A NA study of Prosthesis User and Amputation; Traumatic, Limb, Lower, sponsored by VA New York Harbor Healthcare System.

Active
Registry status
NA
Development phase
91
Enrollment target
1
Study location

NCT03505983: Active NA study of Prosthesis User and Amputation; Traumatic, Limb, Lower, sponsored by VA New York Harbor Healthcare System.

NCT03505983 is a NA study of Prosthesis User and Amputation; Traumatic, Limb, Lower that is active but no longer recruiting, run by VA New York Harbor Healthcare System. The registered enrollment target is 91 participants, above the 50-participant average among 12 other Prosthesis User trials with a reported enrollment target (82% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03505983, a NA study of Prosthesis User and Amputation; Traumatic, Limb, Lower, is active but no longer recruiting, sponsored by VA New York Harbor Healthcare System.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
91 participants
Enrollment target
1
Study location

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.

Primary Outcome

The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.

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

FieldValue
Enrollment Target 91 participants
Start Date 2018-03-07
Est. Completion 2026-09-01
Phase NA

What the registry record for NCT03505983 still lists

NCT03505983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 50-participant average among 12 other Prosthesis User trials with a reported enrollment target (82% higher).

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.

NCT03505983 reports a single indexed study location in New York.

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.

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).

Who is sponsoring clinical trial NCT03505983?

This trial is sponsored by VA New York Harbor Healthcare System, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Prosthesis User

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03505983's enrollment target sits among peer trials

91 4th of 12 higher than 9 of 12 other Prosthesis User trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prosthesis User trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03505983, the US trial registry maintained by the National Library of Medicine. NCT03505983 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.