An observational study in Healthy and Skin Ulcer, sponsored by National Institute of Dental and Craniofacial Research (NIDCR). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Institute of Dental and Craniofacial Research (NIDCR) · Observational
This study will compare blood from healthy volunteers and with wound fluid and tissue samples from patients with acute and chronic wounds enrolled in other NIH studies. Chronic wounds, such as venous leg ulcers, pressure sores, ischemic ulcers and diabetic foot ulcers, affect more than 4 million Americans each year and cost about $9 billion to treat. The nature of these wounds is not well understood and treatments are not always successful, for unknown reasons. Blood collected from healthy volunteers will be used to prepare a model for studying various processes involved in wound healing.
Normal healthy volunteers 21 years of age and older who do not smoke and have no medical problems of the heart, bones, muscles, stomach, lungs, blood, or nervous system, do not have problems going to the bathroom, and have no infections may be eligible for this study.
Participants will be interviewed briefly for information on their date of birth, gender, ethnic identity and medical history and will have a brief physical examination, including a check of height and weight, vital signs and heart and lung sounds. About 14 milliliters (2 tablespoons) of blood will be drawn from the arm.
Chronic wounds are "any interruption on the continuity of the body's tissue that requires a prolonged time to heal, does not heal, or recurs" (Wysocki, 1996). Venous leg ulcers, pressure sores, ischemic ulcers, and diabetic foot ulcers are examples of chronic wounds. These kinds of wounds affect over 4 million Americans each year and cost over $9 billion to treat. The pathophysiology of these wounds is not well understood and therapies directed at healing these wounds are not always successful for unknown reasons. To better understand the pathophysiology of these wounds we propose to collect blood by venipuncture from healthy volunteers. Blood will be used to prepare blood and plasma derived serum for use in an in vitro wound healing model and Boyden chamber assays to study cell migration, adhesion, genetic expression, expression of cell surface receptors, and protein expression to construct a profile of various healing processes. This baseline data will be used for studying the effect of acute and chronic wound fluids on cell migration, adhesion, genetic expression, expression of cell surface receptor and protein expression in an in vitro wound model (protocols to be submitted for each patient population).
80 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's enrollment of 999 is above the median of 113 across 11 observational studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →National Institute of Dental and Craniofacial Research (NIDCR) is the lead sponsor of 94 studies on the registry; 9 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
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Healthy volunteers, 21 years of age and older.
Male or female.
EXCLUSION CRITERIA
Volunteers with known neurological, cardiac, endocrine, skeletal, gastrointestinal, immunological, neoplastic, pulmonary, urologic, hematologic, or infectious disease.
Volunteers taking medications to treat a known diagnosed illness.
Smoker.
Children will not be used because chronic wounds are rarely seen in this population.
The record gives a start of Oct 2000 and a completion of Oct 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2002. You cannot join it, but the record below documents what was studied.
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National Institute of Dental and Craniofacial Research (NIDCR) →