Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses (CFO)

Carbon Fiber Off-Loading Orthosis

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Peripheral Neuropathy; Orthotic Device
• Intervention / Treatment: Device: Carbon Fiber Off Loading Orthosis (CFO)

Detailed Description

The long term goal of this research is the successful incorporation of carbon fiber into an off loading device will provide protection to the insensate foot of people with diabetes by reducing localized peak pressures, and thus the risk of recurrence neuropathic foot wounds and fractures, while improving ankle power at push off that will allow individuals with loss of ankle muscle function to walk faster and return to dynamic activities required in their jobs and for full function in the community. The overall goal of this proposal is to determine effects of carbon fiber off loading orthoses (CFO) design characteristics (lay up and geometry of strut) on brace strength, weight, power return capacity, plantar off-loading and participant comfort using FE models, ex-vivo testing and human testing.

First, a CFO will be fabricated using geometry consistent with the current clinical standard. This representative CFO will serve as a baseline from which a finite element (FE) model will be built. The model will be altered as desired to determine the effects of variable design characteristics. The FE model will estimate brace deflection and stress when the CFO is designed with various lay up designs and brace thicknesses. We will use results from the FE model to fabricate a new CFO for study participants.

We will then measure peak plantar pressures during walking while the participants are barefoot, wearing the CFO consistent with current clinical standards, and wearing the new CFO fabricated based on the results of the FE model. We will also measure plantarflexor power during walking while the participants are wearing the CFO consistent with current clinical standards and while wearing the CFO designed based on the results of the FE model. It is believed that the FE model driven CFO design will lead to improved brace strength while reducing plantar pressure compared to barefoot and will have similar plantarflexor power as the CFO based on current clinical standards.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Daily life includes a minimum of moderate activity level (variable cadence walking)
2. Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
3. Diagnosis of diabetes mellitus and peripheral neuropathy
4. Ability to ambulate in the community (K-level ≥ 2)
5. Age > 21 years

Exclusion Criteria:

1. Unable to ambulate and complete testing required for study participation.
2. Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.
3. Neurological diseases that affects walking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: People using a CFO; People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Device: Carbon Fiber Off Loading Orthosis (CFO); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plantar Pressure	Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.	Participant was tested in new brace (based on FE model) after wearing for 1 week.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Mary Hastings, DPT, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2016
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: 201308105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No