HP Arize 3D Orthotics for Planar Fasciitis

NCT05707013 | Active Not Recruiting

• 1 other identifier: 1876792
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Keywords

orthotics

Outcome Measures

Primary Outcomes (1)

• Patient-reported compliance and satisfaction with orthotics.

  Patient-reported compliance with traditionally fabricated or 3D-printed orthotics will be assessed at 4 weeks and 8 weeks post-initiation of orthotic wearing via a study-specific survey. This survey includes questions related to how often the patient wore their orthotics, the ease of the process, and fit and feel of the orthotics, and any experienced side effects. This survey was developed by the research team and includes subjective responses to questions; there is no score associated with this assessment.

  8 weeks

Secondary Outcomes (1)

• Patient-reported secondary site pain following implementation of orthotics.

  8 weeks

Study Arms (2)

HP Arize 3D-Printed Orthotics

EXPERIMENTAL

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

Device: HP Arize 3D-Printed Orthotics

Traditional Orthotics

ACTIVE COMPARATOR

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

Device: Traditional Orthotics

Interventions

HP Arize 3D-Printed Orthotics DEVICE

Custom 3D-printed orthotics manufactured by HP.

HP Arize 3D-Printed Orthotics

Traditional Orthotics DEVICE

Traditionally fabricated custom orthotics manufactured by a local supplier.

Traditional Orthotics

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Midlands: lead
• Hewlett-Packard (HP): collaborator

Study Sites (1)

Prisma Health - Midlands

Lexington, South Carolina, 29072, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: January 19, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)