NCT00522002

Brief 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 therapy, and assess the impact of lower extremity ulcers on quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

August 28, 2007

Last Update Submit

August 28, 2017

Conditions

Connective Tissue DiseasesBlood Coagulation DisordersLeg UlcersRheumatoid ArthritisSystemic Lupus ErythematosusSystemic SclerodermaMixed Connective Tissue Disease

Keywords

Connective tissue diseasesBlood coagulation disordersLeg ulcersRheumatoid ArthritisSystemic Lupus ErythematosusSystemic SclerodermaMixed Connective Tissue Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with refractory lower extremity ulcers

You may qualify if:

  • 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

You may not qualify if:

  • Lower extremity ulcers in the setting of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Shanmugam

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Connective Tissue DiseasesBlood Coagulation DisordersLeg UlcerArthritis, RheumatoidLupus Erythematosus, SystemicScleroderma, SystemicMixed Connective Tissue Disease

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesHematologic DiseasesHemic and Lymphatic DiseasesSkin UlcerSkin DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Victoria K. Shanmugam, MD

    Georgetown University Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas R. Cupps, MD

    Georgetown University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

US(1)