Clinical Trial: CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Connective Tissue Disease Leg Ulcer Etiology Study

Brief Summary: To explore the hypothesis that leg ulcers are associated with hypercoagulable states, the CLUE study will evaluate patients with connective tissue disease associated leg ulcers, to identify risk factors (especially hypercoagulability and immunologic characteristics), characterize pathogenesis, predict response to therapy, and assess the impact of lower extremity ulcers on quality of life.

Detailed Summary:

Patients with non-healing leg ulcers who are over 18 years old will be eligible to enter the CLUE study. All eligible patients will be evaluated in both the Georgetown University Rheumatology Clinic and the Georgetown University Comprehensive Wound Healing Center. Since these evaluations are part of our routine care of patients, you need to have health insurance to be evaluated in our clinics.

WHAT DOES THE STUDY INVOLVE?

Enrollment in the CLUE study is voluntary, and will not affect your medical care at Georgetown University Hospital.

The standard evaluation of patients with non-healing leg ulcers evaluated in the Georgetown Division of Rheumatology includes an initial history and physical examination, along with hypercoagulable and autoimmune profiles. If this is your first visit to the rheumatology clinic the initial laboratory testing will require 3.5 tablespoons of blood. We will ask for your permission to review your medical record for previous blood test results so that you do not undergo unnecessary testing.

If you agree to participate in the CLUE study we will ask you to sign a consent form, allow us to photograph and measure your ulcers, and complete three brief pain and quality-of-life questionnaires.

If you continue to follow-up with the Georgetown Division of Rheumatology we will ask you to repeat these questionnaires at each clinic visit. If you prefer to follow-up elsewhere, we will ask for your permission to telephone you once per year to find out how your leg ulcers are doing.

WHAT TREATMENTS ARE AVAILABLE?

The CLUE Study is not a treatment trial. Treatment of
Sponsor: Georgetown University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Georgetown University

Dates:
Date Received: August 28, 2007
Date Started: August 2007
Date Completion:
Last Updated: July 14, 2010
Last Verified: July 2009