Plantar FascitisNCT05707013
HP Arize 3D Orthotics for Planar Fasciitis
A study testing HP Arize 3D-Printed Orthotics and Traditional Orthotics in people with Plantar Fascitis, run by Prisma Health-Midlands at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- HP Arize 3D-Printed Orthotics and Traditional Orthotics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Diagnosis of plantar fasciitis
- Access to methods of electronic communication (i.e., email)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health - Midlands
Lexington, South Carolina, 29072
About this study
Official title: Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics
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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- HP Arize 3D-Printed Orthotics, Traditional Orthotics
- Keywords
- orthotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP Arize 3D-Printed OrthoticsDevice
Custom 3D-printed orthotics manufactured by HP.
Traditional OrthoticsDevice
Traditionally fabricated custom orthotics manufactured by a local supplier.
| Study group | Role | What they receive |
|---|---|---|
| HP Arize 3D-Printed Orthotics | Experimental | Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis. Receives: Device: HP Arize 3D-Printed Orthotics |
| Traditional Orthotics | Active comparator | Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis. Receives: Device: Traditional Orthotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Patient-reported secondary site pain following implementation of orthotics.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start19 Jan 2023
- Primary completion10 Apr 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Midlands
- Sponsor type
- University, hospital or other
- Collaborators
- Hewlett-Packard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707013
- Sponsor's protocol ID
- 1876792
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics
- ClinicalTrials.gov ID
- NCT05707013
- Acronym / sponsor ID
- 1876792
- Conditions
- Plantar Fascitis
- Keywords
- orthotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prisma Health-MidlandsUniversity, hospital or other
- Collaborators
- Hewlett-Packard
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis.
| Arm | Type | Receives |
|---|---|---|
| HP Arize 3D-Printed Orthotics | Experimental | Device: HP Arize 3D-Printed OrthoticsPatients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis. |
| Traditional Orthotics | Active comparator | Device: Traditional OrthoticsPatients will receive traditionally fabricated orthotics for treatment of plantar fasciitis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Diagnosis of plantar fasciitis
- Access to methods of electronic communication (i.e., email)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP Arize 3D-Printed OrthoticsCustom 3D-printed orthotics manufactured by HP. | Device | HP Arize 3D-Printed Orthotics |
| Traditional OrthoticsTraditionally fabricated custom orthotics manufactured by a local supplier. | Device | Traditional Orthotics |
Primary outcome
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.
1 secondary outcome
Patient-reported secondary site pain following implementation of orthotics.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HP Arize 3D-Printed Orthotics and Traditional Orthotics in people with Plantar Fascitis, run by Prisma Health-Midlands at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported compliance and satisfaction with orthotics. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.