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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522002
First Posted: August 29, 2007
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
Victoria Shanmugam, George Washington University
  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: 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 Victoria Shanmugam, George Washington University:

Enrollment: 40
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

  Eligibility

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 Submitted: August 28, 2007
First Posted: August 29, 2007
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