What is the mechanism of action of this treatment?

Common treatments for foot injuries and disorders include custom fit carbon fiber braces, orthotic insoles, and therapeutic shoes. These treatments primarily work by providing structural support to the foot, enhancing stability, redistributing weight, and restricting joint motion. Custom fit carbon fiber braces, in particular, improve function by reducing pain and correcting gait abnormalities. This is crucial for patients as it not only alleviates discomfort but also enhances mobility and overall quality of life, allowing for better participation in daily activities.

What side effects are associated with this type of intervention?

The most common treatments for foot injuries and disorders using custom fit carbon fiber braces and similar orthotic devices generally have minimal side effects. However, some patients may experience skin irritation or mild erythema due to prolonged contact with the brace. In rare cases, improper fit or prolonged use can lead to pressure sores or skin breakdown. Additionally, there may be initial discomfort or difficulty in adjusting to the brace. It is important for patients to have regular follow-ups with their healthcare provider to ensure proper fit and to address any issues promptly.

What prior FDA approvals exist?

The FDA has approved various treatments for foot injuries and disorders that provide structural support, enhance stability, reduce pain, and improve function. These include custom orthotic devices and braces, such as ankle-foot orthoses (AFOs) and other supportive footwear. These devices are designed to redistribute weight, restrict joint motion, and facilitate ambulation, thereby improving patient outcomes. While specific FDA approvals for custom fit carbon fiber braces may not be detailed, the general category of orthotic devices and supportive braces is well-recognized for managing severe lower leg injuries and related conditions.

What other types of research exist?

Promising novel alternatives to custom fit carbon fiber braces for foot injuries and disorders include: 1) 3D printed orthoses, which offer customized fit and potentially improved comfort and function; 2) Therapeutic footwear with outsole modifications, which can optimize pressure distribution and enhance gait; and 3) Intrepid Dynamic Exoskeletal Orthosis, which provides dynamic response and compensates for restricted ankle movement to improve walking gait.

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Ankle Foot Orthosis

Ankle Foot Orthoses for Foot Injuries (AFOCE Trial)

N/A

Waitlist Available

Led By Jason M. Wilken, PT, PhD

Research Sponsored by Jason Wilken

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages: 18-65

Limited pain free ankle motion (DF<10deg or PF<20deg)

Must not have

Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities

Ankle weakness as a result of spinal cord injury or central nervous system pathology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two types of custom-fit carbon fiber leg braces to help adults who had serious lower leg injuries and still have trouble moving. The braces are designed to give extra support and make it easier to walk. Researchers will compare how well each brace works by measuring things like balance, speed, and comfort.

Who is the study for?

This trial is for adults aged 18-65 who have had a severe lower leg injury below the knee over two years ago, can walk at least 50 feet without support, and are experiencing mechanical pain. They must not be pregnant, require a knee stabilizing device for daily activities, or have conditions that would interfere with testing like severe brain injuries or heart conditions.

What is being tested?

The study compares two custom-fit carbon fiber braces: Reaktiv AFO and PhatBrace AFO. It aims to determine which brace better improves function after serious lower leg injuries by assessing their form, fit, and function in participants' outcomes.

What are the potential side effects?

While specific side effects aren't listed for wearing these orthoses (braces), potential issues could include skin irritation from the brace material, discomfort during use, or an adjustment period to walking with the new device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have limited movement in my ankle without pain.

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I am considered for amputation due to severe ankle/foot problems.

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I have weakness in my ankle when trying to point my toes down.

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I can walk 50 feet without needing a cane or crutch.

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I experience significant pain in my foot when putting weight on it.

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I have had or am a candidate for ankle or hindfoot fusion surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a device to help stabilize my knee for daily activities.

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I have ankle weakness due to a spinal cord injury or brain condition.

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I have visual or hearing issues that affect my walking or following instructions.

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My pain is more than 8 out of 10 when I walk.

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My BMI is over 45.

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I do not have severe health issues that would stop me from undergoing tests.

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I have a condition that limits the use of my opposite limb.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10 meter shuttle run (10M Shuttle - Timed)

Activities-Specific Balance Confidence (ABC)

Ankle joint power

+11 more

Secondary study objectives

Ankle joint moment

PROMIS Patient reported outcomes for satisfaction with participation in social activities

Paffenbarger Physical Activity Questionnaire

Other study objectives

PROMIS Patient reported outcomes for depression

PROMIS Patient reported outcomes for pain behavior

PROMIS Patient reported outcomes for satisfaction with participation in social roles

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: BAExperimental Treatment2 Interventions

Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.

Group II: ABExperimental Treatment2 Interventions

Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reaktiv AFO

2020

N/A

~60

PhatBrace AFO

2020

N/A

~60

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot injuries and disorders include custom fit carbon fiber braces, orthotic insoles, and therapeutic shoes. These treatments primarily work by providing structural support to the foot, enhancing stability, redistributing weight, and restricting joint motion. Custom fit carbon fiber braces, in particular, improve function by reducing pain and correcting gait abnormalities. This is crucial for patients as it not only alleviates discomfort but also enhances mobility and overall quality of life, allowing for better participation in daily activities.

Custom shoe therapy. Current concepts, designs, and special considerations.Multi-segment foot models and their use in clinical populations.Effect of Full-Length Carbon Fiber Insoles on Lower Limb Kinetics in Patients With Midfoot Osteoarthritis: A Pilot Study.