NCT00006437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2000

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2002

First QC Date

November 3, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

MMPProteasesAdhesionMigrationExtracellular Matrix

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers, 21 years of age and older.
  • Male or female.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 1372338BACKGROUND
  • 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.

    PMID: 10471461BACKGROUND
  • 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.

    PMID: 2467620BACKGROUND

MeSH Terms

Conditions

Skin UlcerTissue Adhesions

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 2000

First Posted

November 6, 2000

Study Start

October 1, 2000

Study Completion

October 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-10

Locations