CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Layered Low Profile Foot +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06468059
NCT06468059N/ACompleted

Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot

Little Room Innovations, LLC·interventional·Posted Jun 21, 2024·Updated Sep 17, 2025

In Brief

A clinical study evaluating Layered Low Profile Foot and Prescribed Ankle for Amputation. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesUnited States

Timeline

N/ACompletedFinished
20252026
First PostedJun 21, 2024
Enrollment StartMar 21, 2024
Primary CompletionJul 16, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.0 years ago

Interventions

Layered Low Profile Footdevice

The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.

Prescribed Ankledevice

The prescribed ankle is the prosthetic ankle that the subject wears for daily use.