Pathophysiology of Chronic Wounds
Primary Purpose
Healthy, Skin Ulcer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring MMP, Proteases, Adhesion, Migration, Extracellular Matrix
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.
Sites / Locations
- National Institute of Dental And Craniofacial Research (NIDCR)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006437
First Posted
November 3, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00006437
Brief Title
Pathophysiology of Chronic Wounds
Official Title
Pathophysiology of Chronic Wounds: Collection of Blood From Healthy Volunteers
Study Type
Observational
2. Study Status
Record Verification Date
October 2002
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Skin Ulcer
Keywords
MMP, Proteases, Adhesion, Migration, Extracellular Matrix
7. Study Design
Enrollment
999 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
National Institute of Dental And Craniofacial Research (NIDCR)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1372338
Citation
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. doi: 10.1111/1523-1747.ep12499839.
Results Reference
background
PubMed Identifier
10471461
Citation
Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
Results Reference
background
PubMed Identifier
2467620
Citation
Wysocki AB. Surgical wound healing. A review for perioperative nurses. AORN J. 1989 Feb;49(2):502, 504-6, 508 passim. doi: 10.1016/s0001-2092(07)66673-3. No abstract available.
Results Reference
background
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Pathophysiology of Chronic Wounds
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