Hypoxia-inducible Factor-1 (HIF-1) Regulated Circulating Angiogenic Cells (CACs) Recruitment in Burn Wound Healing

NCT00796627 | Terminated Results

• 1 other identifier: NA_00018037
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wound Healing; Burns

Keywords

Wound Healing; Burns; HIF-1; CAC

Outcome Measures

Primary Outcomes (4)

• The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury

  Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.

  baseline

• Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury

  Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.

  0 to 24 hours post-operative

• Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury

  Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.

  49 to 72 hours post-operative

• Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury

  Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.

  73 hours to 6 weeks post-operative

Study Arms (2)

Healthy volunteers

SHAM COMPARATOR

Healthy volunteers with no burn wounds Volunteers donate blood that will be studied in comparison to patients who have sustained burns. The circulating "bone marrow stem cells" will be counted and compared to the levels in burn patients. Six 12 ml tubes will be taken for the study. You will not be compensated. But you will be helping to advance science if you join the study.

Genetic: Healthy volunteers

Burn volunteer

ACTIVE COMPARATOR

To recruit burn wound patients with defined clinical criteria for study. A second-degree burn of at least 10 cm2 to up to 95% BSA; age = 14-75 years; BP \> 100 mm Hg systolic; heart rate \< 100 beats/minute; urine output \> 30 ml/hour; area of burn \< 20% of BSA; body temperature = 98.5-101 degrees Fahrenheit; serum albumin \> 3 mg/ml; and informed consent. We will also obtain a history regarding the presence or absence of risk factors that may affect CAC numbers: hypertension \> 1 year; smoking \> 2 pack-years or within the last year; diabetes mellitus; and family history of premature coronary artery disease (men \< 55 and women \< 65 years of age).Six 12 ml tubes will be taken at 5 time points

Other: Burn volunteers

Interventions

Healthy volunteers GENETIC

Comparison of healthy volunteers to burn wounded volunteers

Healthy volunteers

Burn volunteers OTHER

Comparison of burn wounded volunteers to healthy volunteers

Also known as: Burn wounds

Burn volunteer

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruitment of patients at the Johns Hopkins Regional Burn Center for study will be based upon the following clinical criteria:
• Second degree scald burn of 10 cm2
• Age between 14 to 75 years
• Burn area equal or less than 95% of Burn Surface Area (BSA)
• Body temperature between 98.5 and 101 degree F
• Informed consent for enrolment into study
• Spanish speaking patients will be included when we have a Spanish consent form available.

You may not qualify if:

• First and third degree burn wounds
• Hemodynamic instability (SBP below 100, Heart Rate (HR) over 100, urine output less than 30 ml/hour
• Area of burn over 20% of BSA
• Hypothermia T\<98.5 or Hyperthermia T\>101 degree F
• Urine output less than 30 ml/hour
• Serum albumin less than 3 mg/ml.
• Subjects weighing less than 50 kg.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Zhang X, Wei X, Liu L, Marti GP, Ghanamah MS, Arshad MJ, Strom L, Spence R, Jeng J, Milner S, Harmon JW, Semenza GL. Association of increasing burn severity in mice with delayed mobilization of circulating angiogenic cells. Arch Surg. 2010 Mar;145(3):259-66. doi: 10.1001/archsurg.2009.285.

  PMID: 20231626 DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. John Harmon
• Organization: Johns Hopkins University

jharmon@jhmi.edu

410-550-0405

Study Officials

• John Harmon, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)