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

This study has been terminated.
(unable to recruit enough patients)
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00796627
First received: November 21, 2008
Last updated: August 5, 2016
Last verified: August 2016
  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: Allocation: Non-Randomized
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 ]

Enrollment: 41
Study Start Date: December 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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
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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796627

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
Principal Investigator: John Harmon, MD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00796627     History of Changes
Other Study ID Numbers: NA_00018037 
Study First Received: November 21, 2008
Last Updated: August 5, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries
Burns

ClinicalTrials.gov processed this record on August 25, 2016