Pathophysiology of Chronic Wounds

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006437
First received: November 3, 2000
Last updated: March 3, 2008
Last verified: October 2002

November 3, 2000
March 3, 2008
October 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00006437 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pathophysiology of Chronic Wounds
Pathophysiology of Chronic Wounds: Collection of Blood From Healthy Volunteers

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).

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Healthy
  • Skin Ulcer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
999
October 2002
Not Provided

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.

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006437
010026, 01-D-0026
Not Provided
Not Provided
National Institute of Dental and Craniofacial Research (NIDCR)
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP