Connective Tissue DiseasesCLUENCT00522002
CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study
An observational study of Connective Tissue Diseases and Blood Coagulation Disorders, run by George Washington University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Connective Tissue Diseases, Blood Coagulation Disorders, Leg Ulcers
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory lower extremity ulcers
Who may be able to join
- 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
Who cannot join
- Lower extremity ulcers in the setting of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Victoria Shanmugam
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the 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.
- Conditions
- Connective Tissue Diseases, Blood Coagulation Disorders, Leg Ulcers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Scleroderma
- Keywords
- Connective tissue diseases, Blood coagulation disorders, Leg ulcers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Scleroderma, Mixed Connective Tissue Disease
- Medical subject headings
- Connective Tissue Diseases, Blood Coagulation Disorders, Leg Ulcer, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Mixed Connective Tissue Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation
- Responsible party
- Principal investigator, Victoria Shanmugam, George Washington University
- Investigators
- Victoria K. Shanmugam, MD, Principal investigator, Georgetown University HospitalThomas R. Cupps, MD, Study chair, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522002
- Sponsor's protocol ID
- IRB 2007-306
- Acronym
- CLUE
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2007
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Disease Leg Ulcer Etiology Study
- ClinicalTrials.gov ID
- NCT00522002
- Acronym / sponsor ID
- CLUE / IRB 2007-306
- Conditions
- Connective Tissue Diseases, Blood Coagulation Disorders, Leg Ulcers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Scleroderma
- Keywords
- Connective tissue diseases, Blood coagulation disorders, Leg ulcers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Scleroderma, Mixed Connective Tissue Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation
- Study start
- Aug 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory lower extremity ulcers
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lower extremity ulcers in the setting of diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria K. Shanmugam, MD principal investigator
Georgetown University Hospital
Thomas R. Cupps, MD study chair
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Blood Coagulation Disorders, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.