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

August 28, 2017 updated by: Victoria Shanmugam, George Washington University

Connective Tissue Disease Leg Ulcer Etiology Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with non-healing leg ulcers who are over 18 years old will be eligible to enter the CLUE study. All eligible patients will be evaluated in both the Georgetown University Rheumatology Clinic and the Georgetown University Comprehensive Wound Healing Center. Since these evaluations are part of our routine care of patients, you need to have health insurance to be evaluated in our clinics.

WHAT DOES THE STUDY INVOLVE?

Enrollment in the CLUE study is voluntary, and will not affect your medical care at Georgetown University Hospital.

The standard evaluation of patients with non-healing leg ulcers evaluated in the Georgetown Division of Rheumatology includes an initial history and physical examination, along with hypercoagulable and autoimmune profiles. If this is your first visit to the rheumatology clinic the initial laboratory testing will require 3.5 tablespoons of blood. We will ask for your permission to review your medical record for previous blood test results so that you do not undergo unnecessary testing.

If you agree to participate in the CLUE study we will ask you to sign a consent form, allow us to photograph and measure your ulcers, and complete three brief pain and quality-of-life questionnaires.

If you continue to follow-up with the Georgetown Division of Rheumatology we will ask you to repeat these questionnaires at each clinic visit. If you prefer to follow-up elsewhere, we will ask for your permission to telephone you once per year to find out how your leg ulcers are doing.

WHAT TREATMENTS ARE AVAILABLE?

The CLUE Study is not a treatment trial. Treatment of your underlying connective tissue disease and leg ulcers will continue according to standard clinical care, as directed by doctors in the Division of Rheumatology and the Comprehensive Wound Healing Center.

In the future, studies testing new medications in patients with lower extremity ulcers may become available, and you may indicate on the consent form whether you would wish to be contacted regarding these studies.

WILL MY INFORMATION BE SECURE?

Information on CLUE study subjects will be stored on a password protected computer which will be kept in a locked room in the Division of Rheumatology. Your personal data will not be stored in this database and information will be identifiable only by a CLUE patient number.

WHAT ARE THE COSTS?

The CLUE Study is not a treatment trial. Just like any other doctors visit, you or your insurance will be charged for your initial evaluation and follow-up visits.

For more information on arranging an initial consultation in the Georgetown Division of Rheumatology, please call (202) 687-8233 and ask for an investigator to call you about the CLUE study.

Before your clinic visit can be scheduled, our staff will request that you have your primary care physician, rheumatologist or wound care specialist fax your previous medical records to our office at (202) 687-8579. If you have had previous scans, arteriograms or X-rays performed, please arrange to collect a copy of the scan and bring it to your appointment.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20037
        • Victoria Shanmugam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with refractory lower extremity ulcers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2007-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Coagulation Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe