Finger Hardness Measure in Scleroderma
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Durometer Skin Assessment in Scleroderma: a Study to Validate This New Tool in the Digital Tufts|
- Fingertip hardness in patients with scleroderma and controls: comparing manual assessment(scale0 - 3) with durometer assessment(scale 0- 100). [ Time Frame: 1 year ] [ Designated as safety issue: No ]Two investigators will compare data from 30 patients with scleroderma and 30 control patients without fingertip inflammation or tightness twice using durometer readings to those done by manual palpation.
|Study Start Date:||April 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111786
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas Osborn, MD||Mayo Clinic|