CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Carbon Fiber Off Loading Orthosis (CFO)device
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/NCT03618628
NCT03618628N/ACompleted
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Carbon Fiber Off-Loading Orthosis

Washington University School of Medicine·interventional·Posted Aug 7, 2018·Updated May 13, 2019

In Brief

A clinical study evaluating Carbon Fiber Off Loading Orthosis (CFO) for Diabetes Mellitus and 2 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the ability of carbon fiber off loading orthoses to reduce plantar pressure while providing an augmented plantarflexor power to improve walking and function. Results of this study could lead to increased use of carbon fiber off loading orthoses for patients with diabetes, peripheral neuropathy, and foot wounds as a way augmenting wound healing and preventing future recurrences of wounds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Peripheral Neuropathy, Orthotic Device
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 7, 2018
Enrollment StartMay 24, 2016
Primary CompletionApr 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.9 years ago

Interventions

Carbon Fiber Off Loading Orthosis (CFO)device

A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.