What is the mechanism of action of this treatment?

Custom foot orthoses, especially those created using 3D printing technology, provide tailored support to the arch of the foot, redistribute pressure, and improve foot alignment. This reduces strain on the plantar fascia, alleviates pain, and promotes healing. The precision of 3D printing allows for a more accurate fit, enhancing the effectiveness of the orthoses. For Plantar Fasciitis patients, this personalized approach is crucial for effective management and relief.

What side effects are associated with this type of intervention?

Common side effects of using custom foot orthoses for plantar fasciitis include initial discomfort as the foot adjusts, potential skin irritation or blisters from friction, and possible worsening of symptoms if the orthotic is not properly fitted. Regular check-ups and adjustments by a healthcare professional are important to minimize these risks.

What prior FDA approvals exist?

The FDA has approved various treatments for plantar fasciitis, including custom-made orthotics, which are designed to provide support and alleviate pain by redistributing pressure on the feet. Traditional custom orthotics have been fabricated using molds and manual adjustments. Recently, advancements in 3D printing technology have allowed for the creation of more precise and tailored orthotic devices. These 3D printed orthotics offer a customized fit based on digital scans of the patient's feet, potentially improving comfort and effectiveness. While specific FDA approvals for 3D printed orthotics for plantar fasciitis are not detailed, the technology represents an evolution of previously approved custom orthotic solutions.

What other types of research exist?

Promising, novel alternatives to 3D printed foot orthotics for plantar fasciitis patients in 2024 include: 1) Shockwave therapy, which uses sound waves to promote healing and reduce pain. 2) Platelet-rich plasma (PRP) injections, which utilize the patient's own blood components to accelerate tissue repair. 3) Customizable, off-the-shelf orthotics that use advanced materials and design for better support and comfort. 4) Biomechanical footwear designed to improve gait and reduce strain on the plantar fascia.

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Orthotics

3D-Printed Orthotics for Plantar Fasciitis

N/A

Waitlist Available

Research Sponsored by Prisma Health-Midlands

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method using 3D printing to make custom foot inserts for people with plantar fasciitis. It aims to see if these inserts work better than traditional ones and if patients are satisfied with them. 3D printed foot orthoses have been shown to be effective in treating various foot conditions, including plantar fasciitis, by improving foot biomechanics and comfort.

Who is the study for?

This trial is for adults over 18 with plantar fasciitis who can communicate electronically. It's not suitable for non-English speakers, Medicare patients, pregnant women, those needing lower leg bracing, or individuals with a history of orthotic use or certain foot conditions.

What is being tested?

The study compares the effectiveness and patient satisfaction between HP Arize 3D-printed orthotics and traditional custom-made ones in treating plantar fasciitis. Participants will receive one type to see which performs better.

What are the potential side effects?

While specific side effects are not listed for wearing orthotics, some may experience discomfort or pain during initial use as their feet adjust to the new support provided by the inserts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patient-reported compliance and satisfaction with orthotics.

Secondary study objectives

Patient-reported secondary site pain following implementation of orthotics.

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

Active Control

Group I: HP Arize 3D-Printed OrthoticsExperimental Treatment1 Intervention

Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis.

Group II: Traditional OrthoticsActive Control1 Intervention

Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis.

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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

Custom foot orthoses, especially those created using 3D printing technology, provide tailored support to the arch of the foot, redistribute pressure, and improve foot alignment. This reduces strain on the plantar fascia, alleviates pain, and promotes healing. The precision of 3D printing allows for a more accurate fit, enhancing the effectiveness of the orthoses. For Plantar Fasciitis patients, this personalized approach is crucial for effective management and relief.