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CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study (CLUE)

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ClinicalTrials.gov Identifier: NCT00522002
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Connective Tissue Diseases Blood Coagulation Disorders Leg Ulcers Rheumatoid Arthritis Systemic Lupus Erythematosus Systemic Scleroderma Mixed Connective Tissue Disease

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Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connective Tissue Disease Leg Ulcer Etiology Study
Study Start Date : August 2007
Primary Completion Date : June 2010
Study Completion Date : June 2010


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with refractory lower extremity ulcers
Criteria

Inclusion Criteria:

  • Patients with refractory lower extremity ulcers
  • Patients with Rheumatoid arthritis, Systemic Lupus Erythematosus, Systemic Scleroderma, Mixed Connective Tissue Disease or with lesions fulfilling a clinical diagnosis of Livedoid Vasculopathy

Exclusion Criteria:

  • Lower extremity ulcers in the setting of diabetes mellitus
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522002


Locations
United States, District of Columbia
Victoria Shanmugam
Washington, D.C., District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Victoria K. Shanmugam, MD Georgetown University Hospital
Study Chair: Thomas R. Cupps, MD Georgetown University Hospital
More Information

Responsible Party: Victoria Shanmugam, Associate Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT00522002     History of Changes
Other Study ID Numbers: IRB 2007-306
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Victoria Shanmugam, George Washington University:
Connective tissue diseases
Blood coagulation disorders
Leg ulcers
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Systemic Scleroderma
Mixed Connective Tissue Disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Ulcer
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Leg Ulcer
Connective Tissue Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Mixed Connective Tissue Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders