UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

NCT06187519 | Completed DMC FDA Device

• 2 other identifiers: UR+AIMSR21DK132666
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout

Outcome Measures

Primary Outcomes (2)

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

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

  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.

  3 years

Study Arms (1)

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[no dose change within the last 30 days\].

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Gout

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• John FitzGerald, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clin Prof, Clinical Chief

Model Details: 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

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: January 2, 2024
• Study Start: March 10, 2025
• Primary Completion: June 18, 2025
• Study Completion: September 3, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)