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Home > "P" Clinical Trials Conditions > Pathophysiology of Chronic Wounds  Pathophysiology of Chronic Wounds
Pathophysiology of Chronic Wounds
For Condition: Healthy,Skin Ulcer
Status: Completed
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: 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.
Details: 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).
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA 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.
Total Enrollment: 999
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010026; 01-D-0026
Study Start Date: October 28, 2000
Record last reviewed: October 1, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006437
Other Skin Ulcer Studies:
1. Interactions of Depressed Mothers with Their Infants
2. Pathophysiology of Chronic Wounds
3. Sample Collections from the Airways of Asthmatic Patients
4. Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers
5. Spinal Cord Plasticity
Related Studies:
Other Skin Ulcer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Pathophysiology of Chronic Wounds
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