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Active, Not Recruiting

NCT Number: NCT05707013

HP Arize 3D Orthotics for Planar Fasciitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Plantar Fascitis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health - Midlands

Lexington, South Carolina, 29072, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HP Arize 3D-Printed Orthotics

Device

Custom 3D-printed orthotics manufactured by HP.

Traditional Orthotics

Device

Traditionally fabricated custom orthotics manufactured by a local supplier.

Primary outcomes

  1. Patient-reported compliance and satisfaction with orthotics.

    Time frame: 8 weeks

    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.

Secondary outcomes

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

    Time frame: 8 weeks

    Patient-reported secondary site pain for patients wearing either traditionally fabricated or 3D-printed orthotics will be assessed at the time of consent, 4 weeks, and 8 weeks post-initiation of orthotic wearing via a study-specific survey. This survey asks patients to provide a pain score and function score for 11 locations on the body. Scores range from 0 to 100, with 0 being no pain or no limitation to physical function, and 100 being the worst pain possible or complete limitation to physical function.

Sponsors and collaborators

Lead sponsor

Prisma Health-Midlands

Other

Collaborators

  • Hewlett-Packard (HP)

Registry information

Official study title

Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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