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Completed

NCT Number: NCT00668473

Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Level of endostatin in skin and serum

    Time frame: At time of of biopsy and blood draw

Secondary outcomes

  1. Level of JAM-A in skin and serum

    Time frame: At time of blood draw and skin biopsy

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

Important dates

Study start
2007
Primary completion
2008
Study completion
2012
First posted
Apr 29, 2008
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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