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

This study has been completed.
American College of Rheumatology Research and Education Foundation
Information provided by:
Georgetown University Identifier:
First received: August 28, 2007
Last updated: July 14, 2010
Last verified: July 2009
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connective Tissue Disease Leg Ulcer Etiology Study

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Estimated Enrollment: 300
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description


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

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
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Please refer to this study by its identifier: NCT00522002

United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
American College of Rheumatology Research and Education Foundation
Principal Investigator: Victoria K. Shanmugam, MD Georgetown University Hospital
Study Chair: Thomas R. Cupps, MD Georgetown University Hospital
  More Information

Responsible Party: Victoria Shanmugam, MD, Georgetown University Hospital Identifier: NCT00522002     History of Changes
Other Study ID Numbers: IRB 2007-306
Study First Received: August 28, 2007
Last Updated: July 14, 2010

Keywords provided by Georgetown 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, Rheumatoid
Lupus Erythematosus, Systemic
Leg Ulcer
Scleroderma, Systemic
Scleroderma, Diffuse
Blood Coagulation Disorders
Hemostatic Disorders
Connective Tissue Diseases
Mixed Connective Tissue Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Ulcer
Skin Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on April 24, 2017