- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111786
Finger Hardness Measure in Scleroderma
June 24, 2014 updated by: Mayo Clinic
Durometer Skin Assessment in Scleroderma: a Study to Validate This New Tool in the Digital Tufts
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 Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Scleroderma and controls without tight skin attending our rheumatology clinic for a regularly schedualled visit
Description
Inclusion Criteria:
- Scleroderm
- Rheumatologic condition not effecting the skin tightness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Osborn, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
April 5, 2010
First Submitted That Met QC Criteria
April 26, 2010
First Posted (Estimate)
April 28, 2010
Study Record Updates
Last Update Posted (Estimate)
June 26, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-007486
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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