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CompletedNCT06187519Updated Nov 24, 2025

UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

An interventional study of Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch in Gout, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Gout

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03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 6 is below the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age > 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR > 60 (within the last 12-months).
  2. 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).
  3. For the 5 patients with gout on urate-lowering therapy (ULT) [no dose change within the last 30 days].

Exclusion criteria

Exclusion Criteria:

  1. Contraindications to miosis, which include acute iritis, narrow-angle glaucoma
  2. Known Hypersensitivity to pilocarpine hydrochloride
  3. Pupillary block glaucoma (ophthalmic solution)
  4. 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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch

    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.

    Device: Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch

Interventions

  • DeviceUric Acid and Metabolite Monitor System (UR+AIMS) skin patch

    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.

06

What researchers measure

Primary outcomes

  1. Evaluate tolerability and adherence of daily recorded patch wear time.

    Daily recorded patch wear time as recorded by mobile phone app.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

07

Study locations

1 site
  • UCLA
    Los Angeles, California 90095, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06187519
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
John D. Fitzgerald, MD, PhD (Clin Prof, Clinical Chief, University of California, Los Angeles) — Principal investigator
First posted
Jan 2, 2024
Start date
Mar 10, 2025
Primary completion
Jun 18, 2025
Completion
Sep 3, 2025
Last update
Nov 24, 2025

Study contacts

John FitzGerald, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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