3D-Printed Orthotics for Plantar Fasciitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Midlands

Disqualifiers: Orthotic use, Neuropathy, Fractures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether 3D-printed orthotics outperform traditional ones in treating plantar fasciitis, a common cause of foot pain. Researchers aim to determine if the new custom orthotics, specifically the HP Arize 3D-Printed Orthotics, can relieve pain and enhance daily comfort. The trial also evaluates patient satisfaction with each type of orthotic and adherence to the treatment plan. Individuals diagnosed with plantar fasciitis who have not previously used orthotic inserts may be suitable candidates for this study. As an unphased trial, it offers an opportunity to explore innovative treatment options and contribute to advancing foot care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these 3D-printed orthotics are safe for treating plantar fasciitis?

Research on 3D-printed orthotics, including those for plantar fasciitis, shows they are generally safe for use. Studies have examined their effectiveness in reducing pressure on the bottom of the foot without increasing pressure elsewhere. This indicates that the orthotics function well and remain comfortable for patients. To date, no major problems have been reported, making them a promising option for individuals with foot pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HP Arize 3D-Printed Orthotics because they bring cutting-edge technology to the treatment of plantar fasciitis. Unlike traditional orthotics, which are typically made through a lengthy and manual process, 3D printing allows for rapid and highly customizable production, tailored specifically to the unique contours of each patient’s foot. This precision could potentially lead to better comfort and effectiveness in alleviating pain. Additionally, the use of 3D printing aims to reduce production time and costs, making it a promising alternative to standard orthotic options.

What evidence suggests that 3D-printed orthotics are effective for plantar fasciitis?

This trial will compare HP Arize 3D-Printed Orthotics with Traditional Orthotics for treating plantar fasciitis. Research has shown that 3D-printed orthotics effectively treat foot problems like plantar fasciitis. These orthotics improve foot movement, which can reduce pain. Studies have found they match traditional orthotics in enhancing comfort and fit. Users of 3D-printed orthotics often report greater satisfaction due to their custom-made design. This personalized fit can lead to better outcomes for those with plantar fasciitis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Access to methods of electronic communication (i.e., email)

You have been diagnosed with plantar fasciitis.

Exclusion Criteria

You have used or been prescribed orthotic inserts in the past.

You have been diagnosed with nerve damage, a recent broken bone, or a bone fracture caused by overuse or repetitive stress.

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for compliance, satisfaction, and secondary site pain after initiation of orthotic wearing

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HP Arize 3D-Printed Orthotics
• Traditional Orthotics

Trial Overview 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.

How Is the Trial Designed?

Group I: HP Arize 3D-Printed Orthotics Experimental Treatment 1 Intervention

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

Group II: Traditional Orthotics Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Prisma Health-Midlands

Lead Sponsor

Trials

24

Recruited

2,800+

Hewlett-Packard (HP)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 30 adults with plantar fasciitis, two types of prefabricated foot orthotics (soft supportive foam and foam covered rigid plastic) significantly reduced pain levels compared to a non-supportive orthotic, which showed no effect.

The foam covered rigid plastic orthotic was found to be the most effective, providing superior pain reduction and quicker onset of relief compared to the soft supportive foam orthotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different orthotic concepts as first line treatment of plantar fasciitis. Walther, M., Kratschmer, B., Verschl, J., et al.[2022]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Baldassin, V., Gomes, CR., Beraldo, PS.[2022]

The study involving 30 healthy male participants demonstrated that a customized 3D-printed heel support insole significantly reduced peak pressure under the heel compared to traditional insoles, indicating improved pressure distribution.

Using the customized insole did not negatively affect midfoot motion function, suggesting it can enhance comfort without compromising foot function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 3D-Printed Heel Support Insoles Based on Arch Lift Improves Foot Pressure Distribution in Healthy People. Jin, H., Xu, R., Wang, S., et al.[2020]

Customized 3D printed ankle-foot orthoses (AFOs) significantly improved comfort and reduced peak pressure in key areas of the foot for patients with plantar fasciitis compared to traditional prefabricated AFOs, as shown in a study of 60 patients over 8 weeks.

After 8 weeks, patients using the customized AFOs reported significantly greater comfort levels than those using prefabricated AFOs, indicating that customized solutions may be more effective in managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. Xu, R., Wang, Z., Ma, T., et al.[2020]

In a study of 30 subjects with unilateral plantar fasciitis, both pre-fabricated orthotics and customised orthotics significantly reduced peak rearfoot pressures, improving pressure distribution compared to flat insoles and bone spur pads.

Bone spur heel pads were found to be ineffective, as they actually increased rearfoot peak pressures, highlighting the importance of using appropriate orthotic devices for managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative trial of the foot pressure patterns between corrective orthotics,formthotics, bone spur pads and flat insoles in patients with chronic plantar fasciitis. Chia, KK., Suresh, S., Kuah, A., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-fasciitis-2023-dd0f7

3D-Printed Orthotics for Plantar Fasciitis · Info for Participants 3D printed foot orthoses have been shown to be effective in treating various foot conditions, including plantar fasciitis, by improving foot biomechanics and ...

2. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05707013?keyword=%22Plantar%20Fascitis%22

HP Arize 3D Orthotics for Planar Fasciitis This pilot study will evaluate the effectiveness and clinical benefit of 3D printed foot orthotics compared to traditionally fabricated custom-made ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12400727/

The current state of 3D-printed orthoses clinical outcomes The main clinical outcomes that were analyzed are gait parameters, functional performance, radiographic measurements, comfort, fit, and ...

4. hp.com hp.com/us-en/newsroom/press-kits/2021/new-arize-customer-orthoses-to-alleviate-foot-pain-for-millions.html

New Arize Custom Orthoses to Help Podiatrists Relieve ... Arize Orthotic Solution enables podiatrists and orthotists to prescribe custom orthoses tailored to their patients' specific needs in less than five minutes.

5. 3dshoes.com 3dshoes.com/3d-innovation/3d-printed-orthotics/

3D Printed Orthotics vs. Traditional – Best for Plantar ... In this article, we compare traditional orthotics with 3D printed alternatives to help you decide which approach may provide the best relief for plantar ...

6. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09070-4

The current state of 3D-printed orthoses clinical outcomes Studies on 3D-printed insoles demonstrated effective plantar pressure redistribution, and increased comfort. While studies on 3D-printed AFOs ...