NCT01111786

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

April 5, 2010

Last Update Submit

June 24, 2014

Conditions

Scleroderma

Keywords

sclerodermaskintightnessdurometer

Outcome Measures

Primary Outcomes (1)

  • Fingertip hardness in patients with scleroderma and controls: comparing manual assessment(scale0 - 3) with durometer assessment(scale 0- 100).

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Scleroderma and controls without tight skin attending our rheumatology clinic for a regularly schedualled visit

You may qualify if:

  • Scleroderm
  • Rheumatologic condition not effecting the skin tightness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Thomas Osborn, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

US(1)