HP Arize 3D Orthotics for Planar Fasciitis

NCT ID: NCT05707013

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2026-06-30

Brief Summary

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Currently 77% of Americans experience foot pain, of which a large portion can be attributed to plantar fasciitis.

The Arize Orthotic solution, developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. This pilot study will evaluate the effectiveness and clinical benefit of 3D printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

Detailed Description

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Currently 77% of Americans experience foot pain, of which a large portion can be attributed to plantar fasciitis. Approximately half of the people with foot pain do not consult a doctor due to cost, convenience, or insurance reasons. To this end, HP will implement an end-to-end system to provide 3D-printed custom orthotic inserts to patients in a fast and efficient manner via their podiatrist.

The Arize Orthotic solution developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. The Arize Orthotic Solution leverages HP 3D Printing technology and aims to further HP's mission to create technology that makes life better for everyone, everywhere.

This pilot study will evaluate the effectiveness and clinical benefit of 3D printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to receive traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HP Arize 3D-Printed Orthotics

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

Group Type EXPERIMENTAL

HP Arize 3D-Printed Orthotics

Intervention Type DEVICE

Custom 3D-printed orthotics manufactured by HP.

Traditional Orthotics

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

Group Type ACTIVE_COMPARATOR

Traditional Orthotics

Intervention Type DEVICE

Traditionally fabricated custom orthotics manufactured by a local supplier.

Interventions

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HP Arize 3D-Printed Orthotics

Custom 3D-printed orthotics manufactured by HP.

Intervention Type DEVICE

Traditional Orthotics

Traditionally fabricated custom orthotics manufactured by a local supplier.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Diagnosis of plantar fasciitis
* Access to methods of electronic communication (i.e., email)

Exclusion Criteria

* Previously prescribed and/or used orthotic inserts
* Requires additional bracing of the lower leg
* Diagnosis of neuropathy, acute fracture, or stress fracture
* Pregnant women
* Non-English speakers
* Medicare patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hewlett-Packard (HP)

UNKNOWN

Sponsor Role collaborator

Prisma Health-Midlands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Prisma Health - Midlands

Lexington, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1876792

Identifier Type: -

Identifier Source: org_study_id

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