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Finger Hardness Measure in Scleroderma

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: April 5, 2010
Last updated: June 24, 2014
Last verified: June 2014
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 Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Fingertip hardness in patients with scleroderma and controls: comparing manual assessment(scale0 - 3) with durometer assessment(scale 0- 100). [ Time Frame: 1 year ]
    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.

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Scleroderma and controls without tight skin attending our rheumatology clinic for a regularly schedualled visit

Inclusion Criteria:

  • Scleroderm
  • Rheumatologic condition not effecting the skin tightness
  Contacts and Locations
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Please refer to this study by its identifier: NCT01111786

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Thomas Osborn, MD Mayo Clinic
  More Information

Responsible Party: Thomas Osborn, MD, Mayo Clinic Identifier: NCT01111786     History of Changes
Other Study ID Numbers: 09-007486
Study First Received: April 5, 2010
Last Updated: June 24, 2014

Keywords provided by Mayo Clinic:

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases processed this record on August 16, 2017