CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study

This study has been completed.

First Received on August 28, 2007. Last Updated on July 14, 2010 History of Changes

Sponsor:	Georgetown University
Collaborator:	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:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Connective Tissue Disease Leg Ulcer Etiology Study

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia systemic scleroderma

MedlinePlus related topics: Bleeding Disorders Connective Tissue Disorders Leg Injuries and Disorders Lupus Rheumatoid Arthritis Scleroderma

U.S. FDA Resources

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

Eligibility

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522002

Locations

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

Investigators

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
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Blood Coagulation Disorders
Hemostatic Disorders
Connective Tissue Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Leg Ulcer
Lupus Erythematosus, Systemic
Mixed Connective Tissue Disease
Ulcer
Joint Diseases

Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Skin Diseases
Skin Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012