HIF-1 Regulated Endothelial Progenitor Cell (EPC) Recruitment in Burn Wound Healing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00796627
First received: November 21, 2008
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

This research is being done to increase knowledge about wound healing and different factors that may affect healing in burn patients.


Condition Intervention
Wound Healing
Burns
Genetic: Healthy volunteers
Genetic: Burn volunteers

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIF-1 Regulated Endothelial Progenitor Cell Recruitment in Burn Wound Healing

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The identification of circulating angiogenic cells in the blood of individuals who have sustained a burn injury. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the time course of release of circulating angiogenic cells into the peripheral blood of individuals who have sustained a burn injury. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy volunteers
Healthy volunteers with no burn wounds
Genetic: Healthy volunteers
Comparison of healthy volunteers to burn wounded volunteers
Other Name: Healthy volunteers
Active Comparator: Burn volunteer
Burn wounded volunteers
Genetic: Burn volunteers
Comparison of burn wounded volunteers to healthy volunteers
Other Name: Burn wounds

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Recruitment of patients at the Johns Hopkins Regional Burn Center for study will be based upon the following clinical criteria:

  1. Second degree scald burn of 10 cm2
  2. Age between 14 to 75 years
  3. Burn area equal or less than 95% of BSA
  4. Body temperature between 98.5 and 101 degree F
  5. Informed consent for enrolment into study
  6. Spanish speaking patients will be included when we have a Spanish consent form available.

Exclusion Criteria:

  1. First and third degree burn wounds
  2. Hemodynamic instability (SBP below 100, HR over 100, urine output less than 30 ml/hour
  3. Area of burn over 20% of BSA
  4. Hypothermia T<98.5 or Hyperthermia T>101 degree F
  5. Urine output less than 30 ml/hour
  6. Serum albumin less than 3 mg/ml.
  7. Subjects weighing less than 50 kg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796627

Contacts
Contact: Dene Noppenberger 410-550-4895 dnoppen1@jhmi.edu
Contact: Guy Marti, MD 410-550-0400 gmarti1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Dene Noppenberger    410-550-4895    dnoppen1@jhmi.edu   
Contact: Guy Marit, MD    410-550-0400    gmarti1@jhmi.edu   
Principal Investigator: John Harmon, MD         
Sub-Investigator: Stephen Milner, MBBS         
Sub-Investigator: Gregg Semenza, MD; Phd         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: John Harmon, MD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Harmon, MD, Johns Hopkins Bayview Medical Center
ClinicalTrials.gov Identifier: NCT00796627     History of Changes
Other Study ID Numbers: NA_00018037
Study First Received: November 21, 2008
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Wound Healing
Burns
HIF-1
EPC

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014