Finger Hardness Measure in Scleroderma

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01111786
First received: April 5, 2010
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition
Scleroderma

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 ] [ 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • Scleroderm
  • Rheumatologic condition not effecting the skin tightness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111786

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

No publications provided

Responsible Party: Thomas Osborn, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01111786     History of Changes
Other Study ID Numbers: 09-007486
Study First Received: April 5, 2010
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
scleroderma
skin
tightness
durometer

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014