Arthropathy of Ankle or FootNCT05462912
Evaluation of Software Generated Customized Foot Orthoses
A study testing custom foot orthotic in people with Arthropathy of Ankle or Foot, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Ankle or Foot
- What is being tested?
- custom foot orthotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
- Between 18 and 65 years of age
- BMI is greater than 18.5 or less than 30
Who cannot join
- Individuals who have had surgery in the lower limbs during this past year.
- Individuals who already have custom-made orthopedic orthoses.
- Patients with active diabetic ulcers or chronic foot pressure ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.
Read the detailed description
The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. An interim analysis will be conducted after all subjects have completed the 30-day time point. This interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.
- Conditions
- Arthropathy of Ankle or Foot
- Being tested
- custom foot orthotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom foot orthoticDevice
The goal of this study is to find out whether the use of software generated custom-made orthopedic foot orthoses improves pain in the long term.
| Study group | Role | What they receive |
|---|---|---|
| Open | Other | Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Receives: Device: custom foot orthotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Patient Use of a 3D Printed Custom Foot Orthotic
The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or pathology.
Secondary:
- To determine whether custom-made foot orthoses generate a significant increase in comfort among individuals with foot pain and/or pathology.
- To determine whether custom-made foot orthoses improve quality of life among individuals with foot pain and/or pathology
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Oct 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: Per sponsor, trial criteria were not followed and the data collected is not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthropathy of Ankle or FootStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Soleit
- Responsible party
- Sponsor
- Investigators
- Eric Giza, MD, Principal investigator, UC Davis Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462912
- Sponsor's protocol ID
- 1771535
- Status last verified
- Jul 2025
- First submitted
- 27 Apr 2022
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Software Generated Customized Foot Orthoses
- ClinicalTrials.gov ID
- NCT05462912
- Acronym / sponsor ID
- 1771535
- Conditions
- Arthropathy of Ankle or Foot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor, trial criteria were not followed and the data collected is not available
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Soleit
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.
Detailed description
The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. An interim analysis will be conducted after all subjects have completed the 30-day time point. This interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted
| Arm | Type | Receives |
|---|---|---|
| Open | Other | Device: custom foot orthoticEach participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
- Between 18 and 65 years of age
- BMI is greater than 18.5 or less than 30
Key exclusion criteria (3 listed)
- Individuals who have had surgery in the lower limbs during this past year.
- Individuals who already have custom-made orthopedic orthoses.
- Patients with active diabetic ulcers or chronic foot pressure ulcers.
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 |
|---|---|---|
| custom foot orthoticThe goal of this study is to find out whether the use of software generated custom-made orthopedic foot orthoses improves pain in the long term. | Device | Open |
Primary outcome
Successful Patient Use of a 3D Printed Custom Foot Orthotic
Time frame: 11 months
The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or pathology. Secondary: 1. To determine whether custom-made foot orthoses generate a significant increase in comfort among individuals with foot pain and/or pathology. 2. To determine whether custom-made foot orthoses improve quality of life among individuals with foot pain and/or pathology
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eric Giza, MD principal investigator
UC Davis Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom foot orthotic in people with Arthropathy of Ankle or Foot, run by University of California, Davis 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 3 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: stopped early, as of the sponsor's last update on 1 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Patient Use of a 3D Printed Custom Foot Orthotic (time frame: 11 months). 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 1 Aug 2025.