Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses (CFO)
Primary Purpose
Diabetes Mellitus, Peripheral Neuropathy, Orthotic Device
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbon Fiber Off Loading Orthosis (CFO)
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Daily life includes a minimum of moderate activity level (variable cadence walking)
- Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
- Diagnosis of diabetes mellitus and peripheral neuropathy
- Ability to ambulate in the community (K-level ≥ 2)
- Age > 21 years
Exclusion Criteria:
- Unable to ambulate and complete testing required for study participation.
- 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.
- Neurological diseases that affects walking
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
People using a CFO
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03618628
First Posted
July 16, 2018
Last Updated
May 10, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03618628
Brief Title
Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses
Acronym
CFO
Official Title
Carbon Fiber Off-Loading Orthosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Peripheral Neuropathy, Orthotic Device
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
People using a CFO
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Carbon Fiber Off Loading Orthosis (CFO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak Plantar Pressure
Description
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.
Time Frame
Participant was tested in new brace (based on FE model) after wearing for 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Daily life includes a minimum of moderate activity level (variable cadence walking)
Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
Diagnosis of diabetes mellitus and peripheral neuropathy
Ability to ambulate in the community (K-level ≥ 2)
Age > 21 years
Exclusion Criteria:
Unable to ambulate and complete testing required for study participation.
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.
Neurological diseases that affects walking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Hastings, DPT
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses
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