Pathophysiology of Chronic Wounds - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	November 3, 2000
Last Updated Date	March 3, 2008
Start Date ^†	October 2000
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00006437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Pathophysiology of Chronic Wounds
Official Title ^†	Pathophysiology of Chronic Wounds: Collection of Blood From Healthy Volunteers
Brief Summary	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.
Detailed Description	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).
Study Phase
Study Type ^†	Observational
Study Design ^†
Condition ^†	Healthy Skin Ulcer
Intervention ^†
Study Arms / Comparison Groups
Publications *	Grinnell F, Ho CH, Wysocki A. Degradation of fibronectin and vitronectin in chronic wound fluid: analysis by cell blotting, immunoblotting, and cell adhesion assays. J Invest Dermatol. 1992 Apr;98(4):410-6. Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. Review. No abstract available. Wysocki AB. Surgical wound healing. A review for perioperative nurses. AORN J. 1989 Feb;49(2):502, 504-6, 508 passim. Review. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	999
Completion Date	October 2002
Primary Completion Date
Eligibility 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.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00006437
Responsible Party
Secondary IDs ^††	01-D-0026
Study Sponsor ^†	National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators ^††
Investigators ^†
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	October 2002
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.