Validation Study of Physical Measurement of Tophi (NCT00175006) | Clinical Trial Compass
CompletedNot Applicable
Validation Study of Physical Measurement of Tophi
13 participantsStarted 2002-11
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.
* The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.
* Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.
* Must be on stable treatment for gout with no medication changes in the past 30 days.
Exclusion Criteria:
* Must be able to return to the clinical site within 10 days.
* Must not have allergy to ink.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Percent Difference in Area Between Visits
Timeframe: Visit 1 (Day 1) and Visit 2 (Days 6-11)