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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618628
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Hastings, PT, DPT, ATC, Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Peripheral Neuropathy Orthotic Device Device: Carbon Fiber Off Loading Orthosis (CFO) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Carbon Fiber Off-Loading Orthosis
Actual Study Start Date : May 24, 2016
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : April 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plantar Pressure [ Time Frame: Participant was tested in new brace (based on FE model) after wearing for 1 week. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618628


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mary Hastings, DPT Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Mary Hastings, PT, DPT, ATC, Washington University School of Medicine:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] June 28, 2018

More Information
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Responsible Party: Mary Hastings, PT, DPT, ATC, Professor of Physical Therapy, Orthopaedic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03618628    
Other Study ID Numbers: 201308105
First Posted: August 7, 2018    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Carbon Fiber
Anti-Infective Agents, Local
Anti-Infective Agents