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CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: United States: Institutional Review Board

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
Blood Coagulation Disorders
Connective Tissue Diseases
Hemostatic Disorders
Leg Ulcer
Lupus Erythematosus, Systemic
Mixed Connective Tissue Disease
Scleroderma, Diffuse
Scleroderma, Systemic
Autoimmune Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Skin Diseases
Skin Ulcer
Vascular Diseases processed this record on March 03, 2015