|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Georgetown University American College of Rheumatology Research and Education Foundation |
|---|---|
| Information provided by: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00522002 |
Purpose
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.
| Condition |
|---|
|
Connective Tissue Diseases Blood Coagulation Disorders Leg Ulcers Rheumatoid Arthritis Systemic Lupus Erythematosus Systemic Scleroderma Mixed Connective Tissue Disease |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Connective Tissue Disease Leg Ulcer Etiology Study |
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2010 |
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 your underlying connective tissue disease and leg ulcers will continue according to standard clinical care, as directed by doctors in the Division of Rheumatology and the Comprehensive Wound Healing Center.
In the future, studies testing new medications in patients with lower extremity ulcers may become available, and you may indicate on the consent form whether you would wish to be contacted regarding these studies.
WILL MY INFORMATION BE SECURE?
Information on CLUE study subjects will be stored on a password protected computer which will be kept in a locked room in the Division of Rheumatology.
Your personal data will not be stored in this database and information will be identifiable only by a CLUE patient number.
WHAT ARE THE COSTS?
The CLUE Study is not a treatment trial. Just like any other doctors visit, you or your insurance will be charged for your initial evaluation and follow-up visits. For more information on arranging an initial consultation in the Georgetown Division of Rheumatology, please call (202) 687-8233 and ask for an investigator to call you about the CLUE study. Before your clinic visit can be scheduled, our staff will request that you have your primary care physician, rheumatologist or wound care specialist fax your previous medical records to our office at (202) 687-8579. If you have had previous scans, arteriograms or X-rays performed, please arrange to collect a copy of the scan and bring it to your appointment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with refractory lower extremity ulcers
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Victoria K Shanmugam, MD | 202-687-8233 | vks4@gunet.georgetown.edu |
| United States, District of Columbia | |
| Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Victoria K. Shanmugam, MD 202-687-8233 vks4@gunet.georgetown.edu | |
| Contact: Thomas R. Cupps, MD 202-687-8233 cuppst@georgetown.edu | |
| Principal Investigator: Victoria K. Shanmugam, MD | |
| Sub-Investigator: Christopher E. Attinger, MD | |
| Sub-Investigator: Thomas R. Cupps, MD | |
| Sub-Investigator: Virginia D. Steen, MD | |
| Sub-Investigator: Kara Couch, CNP | |
| Principal Investigator: | Victoria K. Shanmugam, MD | Georgetown University Hospital |
| Study Chair: | Thomas R. Cupps, MD | Georgetown University Hospital |
More Information
| Responsible Party: | Georgetown University Hospital ( Victoria Shanmugam, MD ) |
| Study ID Numbers: | IRB 2007-306 |
| Study First Received: | August 28, 2007 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00522002 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Connective tissue diseases Blood coagulation disorders Leg ulcers Rheumatoid Arthritis |
Systemic Lupus Erythematosus Systemic Scleroderma Mixed Connective Tissue Disease |
|
Autoimmune Diseases Skin Diseases Hematologic Diseases Lupus Blood Coagulation Disorders Ulcer Joint Diseases Vascular Diseases Arthritis, Rheumatoid Rheumatic Diseases Hemostatic Disorders Hemorrhagic Disorders |
Sharp Syndrome Lupus Erythematosus, Systemic Musculoskeletal Diseases Mixed Connective Tissue Disease Arthritis Connective Tissue Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Ulcer Leg Ulcer |
|
Autoimmune Diseases Skin Diseases Immune System Diseases Hematologic Diseases Blood Coagulation Disorders Ulcer Joint Diseases Vascular Diseases Arthritis, Rheumatoid Rheumatic Diseases Hemostatic Disorders Pathologic Processes |
Hemorrhagic Disorders Lupus Erythematosus, Systemic Musculoskeletal Diseases Mixed Connective Tissue Disease Arthritis Connective Tissue Diseases Scleroderma, Diffuse Cardiovascular Diseases Scleroderma, Systemic Skin Ulcer Leg Ulcer |