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Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

NCT ID: NCT00668473

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-01-31

Brief Summary

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We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.

Detailed Description

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Systemic sclerosis (SSc) is a connective tissue disease that is characterized by fibrosis of the skin and internal organs. One of the earliest pathologic changes in patients with SSc is damage to the blood vessels. Many abnormalities have been found in the inner layer of the blood vessel, the enothelial tissue. It is known that there are mediators in the blood and tissues of the body that affect the endothelial tissue. These are called angiogenic (promote blood vessel formation) and angiostatic (inhibit blood vessel formation) mediators. Many of these mediators have been examined in the peripheral blood of patients with SSc, but fewer of these mediators have been examined at the site of action, in the tissue near the microvasculature. We hypothesize that there are differences in the levels of angiogenic/angiostatic mediators between healthy subjects and subjects with SSc. In addition, we propose that there are differences at skin sites that have varying levels of involvement with SSc of these angiogenic/angiostatic factors in subjects with SSc.

Conditions

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Systemic Sclerosis

Keywords

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systemic sclerosis angiogenesis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Subjects with diffuse scleroderma

No interventions assigned to this group

2

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Meet American College of Rheumatology criteria for systemic sclerosis
2. Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face
3. Persons with no chronic health conditions

Exclusion Criteria

1. Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness
2. Persons with autoimmune diseases other than systemic sclerosis
3. Persons treated with cyclophosphamide in the last 8 weeks
4. Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV
5. Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kristine Phillips

clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

James R Seibold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Alisa E Koch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Julie A Konkle, BSN

Role: STUDY_DIRECTOR

University of Michigan

Locations

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University of Michigan Hospitals

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00011196

Identifier Type: -

Identifier Source: org_study_id