At a glance
ClinicalIndex Comparison RecordN/ACompleted· 13 enrolled
Drug / intervention
Measurement of Tophi to validate procedureother
Likely dose
Not stated in record
Key inclusion· 5
- ✓At least 1 palpable gouty tophus nodule in foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis per ACR criteria.
- ✓Tophus must be solid, round, non-tender, intact, and larger than 10 mm in both length and width.
- ✓Joints nearest and immediately adjacent to selected tophus must not be acutely inflamed.
- ✓On stable treatment for gout with no medication changes in the past 30 days.
Key exclusion· 1
- ✕Allergy to ink.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
In Brief
An observational study evaluating Measurement of Tophi to validate procedure for Gout. Completed, enrolled 13 participants.
Detailed Summary
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGout
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2002
Primary CompletionJan 2003
First PostedSep 2005
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartNov 1, 2002
Primary CompletionJan 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.8 years ago
Interventions
Measurement of Tophi to validate procedureother
Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.