Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006437
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-11-03
Brief Title:
Pathophysiology of Chronic Wounds
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pathophysiology of Chronic Wounds Collection of Blood From Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 bodys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-D-0026 | None | None | None |