NCT01111786

Finger Hardness Measure in Scleroderma

Durometer Skin Assessment in Scleroderma: a Study to Validate This New Tool in the Digital Tufts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known condition that should cause increased skin hardness in the fingers with undergo examination by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers on 2 separate occasions. There will be 1 hour between individual observer's scorings. Observers will be blinded from the observer's scores and from their previous scores. Results will be tabulated and compared for manual scores versus durometer measurements, intra-observer scores by both methods and inter-observer scores by both methods.

Detailed description

It is pretty straightforward. We will measure and record the hardness of the digital tufts on ten digits by palpation and the hardness in the same area by using a durometer. We will repeat this one hour later. Scores will be compared as a measure of how consistent and precise they are.

Conditions

• Scleroderma

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-04-28
• Last updated: 2014-06-26

Locations

1 site across 1 country: United States