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Completed

NCT Number: NCT06187519

UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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].

Exclusion criteria

  • 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).

Treatment and study plan

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

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Cutaneous Uric Acid and Metabolite Monitor System (UR+AIMS) Lab Validation

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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