Clinical trial NCT05707013: HP Arize 3D Orthotics for Planar Fasciitis
Official title: Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Plantar Fascitis
Keywords: orthotics
Lead sponsor: Prisma Health-Midlands
Sponsor class: OTHER
Collaborators: name: Hewlett-Packard (HP)
First posted: 2023-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported compliance and satisfaction with orthotics.
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient-reported secondary site pain following implementation of orthotics.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Prisma Health - Midlands
state: South Carolina
Study officials:
References: