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Pathophysiology of Chronic Wounds

This study has been completed.

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006437
  Purpose

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.


Condition
Healthy
Skin Ulcer

U.S. FDA Resources

Study Type:   Observational
Official Title:   Pathophysiology of Chronic Wounds: Collection of Blood From Healthy Volunteers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   999
Study Start Date:   October 2000
Estimated Study Completion Date:   October 2002

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).

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006437

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


Publications:

Study ID Numbers:   010026, 01-D-0026
First Received:   November 3, 2000
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00006437
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
MMP  
Proteases  
Adhesion  
Migration  
Extracellular Matrix  

Study placed in the following topic categories:
Skin Diseases
Ulcer
Adhesions
Healthy
Skin Ulcer

ClinicalTrials.gov processed this record on October 03, 2008




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