Diabetes MellitusCFONCT03618628
Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses
A study testing Carbon Fiber Off Loading Orthosis (CFO) in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathy, Orthotic Device
- What is being tested?
- Carbon Fiber Off Loading Orthosis (CFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2016to 12 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy, Orthotic Device
- Being tested
- Carbon Fiber Off Loading Orthosis (CFO)
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| People using a CFO | Experimental | 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. Receives: Device: Carbon Fiber Off Loading Orthosis (CFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participant was tested in new brace (based on FE model) after wearing for 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start24 May 2016
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Hastings, PT, DPT, ATC, Washington University School of Medicine
- Investigators
- Mary Hastings, DPT, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618628
- Sponsor's protocol ID
- 201308105
- Acronym
- CFO
- Status last verified
- May 2019
- First submitted
- 16 Jul 2018
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Fiber Off-Loading Orthosis
- ClinicalTrials.gov ID
- NCT03618628
- Acronym / sponsor ID
- CFO / 201308105
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy, Orthotic Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 24 May 2016 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People using a CFO | Experimental | Device: Carbon Fiber Off Loading Orthosis (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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | People using a CFO |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Hastings, DPT principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Fiber Off Loading Orthosis (CFO) in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plantar Pressure (time frame: Participant was tested in new brace (based on FE model) after wearing for 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.