GoutNCT06187519
UR+AIMS Gout Wearable Skin Uric Acid Monitor Study
A study testing Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch in people with Gout, run by University of California, Los Angeles at 1 site in United States.
Trial summary
15 patients with gout [10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout
- What is being tested?
- Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR > 60 (within the last 12-months).
- For the 10 patients with gout off urate-lowering therapy (ULT) [no Allopurinol, febuxostat, or probenecid prescription within the last 6-months] and serum urate (SU) > 7 mg/dL (within the last 12-months).
- For the 5 patients with gout on urate-lowering therapy (ULT) [no dose change within the last 30 days].
Who cannot join
- Contraindications to miosis, which include acute iritis, narrow-angle glaucoma
- Known Hypersensitivity to pilocarpine hydrochloride
- Pupillary block glaucoma (ophthalmic solution)
- Subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and Sprite).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation
15 patients with gout [10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.
Read the detailed description
First Visit at the UCLA Human Nutrition Center:
- Patients will sign the informed consent, then answer some study questionnaires.
- The Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch and the study mobile device will be provided.
- Study nurse will start an IV for pre and post blood draws.
- Patients will be provided a standardized high-purine meal within 15 minutes. Pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours).
- Then patients will be sent home with the skin patch and study mobile device.
Community 7-day observation period:
- Patients will be asked to apply a study patch each morning before their first meal of the day. The patch should be removed at the end of the day and put under water.
- The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep. Patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.
- Conditions
- Gout
- Being tested
- Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uric Acid and Metabolite Monitor System (UR+AIMS) skin patchDevice
The intervention tested is the system (patch and mobile device/phone for reporting) that provides patients with better knowledge (test results) about the impact of their daily dietary choices on their uric acid levels.
| Study group | Role | What they receive |
|---|---|---|
| Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch | Experimental | 15 patients with gout will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch. Receives: Device: Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate tolerability and adherence of daily recorded patch wear time.
Daily recorded patch wear time as recorded by mobile phone app.
Measured: 3 years
Recording of uric acid (and oxypurinol) measurements while wearing patch.
Recording of uric acid (and other metabolites e.g., uric acid, oxypurinol, ethanol) measurements while wearing patch recorded by patch Bluetooth to mobile phone.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start10 Mar 2025
- Primary completion18 Jun 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 15 patients with gout \[10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)\] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John D. Fitzgerald, MD, PhD, University of California, Los Angeles
- Investigators
- John FitzGerald, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187519
- Sponsor's protocol ID
- UR+AIMS
- Other IDs
- R21DK132666
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation
- ClinicalTrials.gov ID
- NCT06187519
- Acronym / sponsor ID
- UR+AIMS
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 2 Jan 2024 (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.
15 patients with gout [10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.
Detailed description
First Visit at the UCLA Human Nutrition Center:
- Patients will sign the informed consent, then answer some study questionnaires.
- The Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch and the study mobile device will be provided.
- Study nurse will start an IV for pre and post blood draws.
- Patients will be provided a standardized high-purine meal within 15 minutes. Pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours).
- Then patients will be sent home with the skin patch and study mobile device.
Community 7-day observation period:
- Patients will be asked to apply a study patch each morning before their first meal of the day. The patch should be removed at the end of the day and put under water.
- The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep. Patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 patients with gout [10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center
| Arm | Type | Receives |
|---|---|---|
| Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch | Experimental | Device: Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch15 patients with gout will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR > 60 (within the last 12-months).
- For the 10 patients with gout off urate-lowering therapy (ULT) [no Allopurinol, febuxostat, or probenecid prescription within the last 6-months] and serum urate (SU) > 7 mg/dL (within the last 12-months).
- For the 5 patients with gout on urate-lowering therapy (ULT) [no dose change within the last 30 days].
Key exclusion criteria (4 listed)
- Contraindications to miosis, which include acute iritis, narrow-angle glaucoma
- Known Hypersensitivity to pilocarpine hydrochloride
- Pupillary block glaucoma (ophthalmic solution)
- Subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and Sprite).
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 |
|---|---|---|
| Uric Acid and Metabolite Monitor System (UR+AIMS) skin patchThe intervention tested is the system (patch and mobile device/phone for reporting) that provides patients with better knowledge (test results) about the impact of their daily dietary choices on their uric acid levels. | Device | Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch |
Primary outcome
Evaluate tolerability and adherence of daily recorded patch wear time.
Time frame: 3 years
Daily recorded patch wear time as recorded by mobile phone app.
Recording of uric acid (and oxypurinol) measurements while wearing patch.
Time frame: 3 years
Recording of uric acid (and other metabolites e.g., uric acid, oxypurinol, ethanol) measurements while wearing patch recorded by patch Bluetooth to mobile phone.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
John FitzGerald, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch in people with Gout, run by University of California, Los Angeles 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 4 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate tolerability and adherence of daily recorded patch wear time. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 24 Nov 2025.