Wound HealingNCT00796627
Hypoxia-inducible Factor-1 (HIF-1) Regulated Circulating Angiogenic Cells (CACs) Recruitment in Burn Wound Healing
A study testing Healthy volunteers and Burn volunteers in people with Wound Healing and Burns, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to increase knowledge about wound healing and different factors that may affect healing in burn patients. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Burns
- What is being tested?
- Healthy volunteers and Burn volunteers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: HIF-1 Regulated Circulating Angiogenic Cell Recruitment in Burn Wound Healing
This research is being done to increase knowledge about wound healing and different factors that may affect healing in burn patients.
Read the detailed description
Burn injuries represent a major public health problem, requiring medical attention for more than one million Americans annually. Despite therapeutic advances, non-healing burn wounds and excessive scarring still result in significant long term physical and psychosocial morbidity. In this study we propose to perform clinical and research to study the role of circulating angiogenic cells (CAC) in promoting burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of animal models of tissue injury ischemia and mobilization of CACs into the peripheral blood has been demonstrated in burn wound patients.
We hypothesize that primary healing of burn wounds is dependent on repair of damaged vasculature, and that bone marrow derived stem cells, circulating angiogenic cells (CAC), play a critical role in the healing process. Furthermore we propose that the transcription factor Hypoxia Inducible Factor 1 alpha (HIF 1 alpha) through production of peptide products of its downstream target genes directs the "homing" of CAC's to the wound where they participate in healing events. The first aim of this study is to correlate mobilization of CAC's into the blood stream with the success of burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of studies. The relationship between mobilization of CAC's and burn wound healing has not been examined. In addition to surveying CAC numbers in the peripheral blood, we will assay levels of the putative mediators of CAC mobilization: Vascular Endothelial Growth Factor (VEGF), Placenta Growth Factor (PLGF), and Stromal Cell-Derived Factor (SDF-1). We hypothesize that individuals who are able to mount a large and sustained mobilization of CAC's into the peripheral blood from the bone marrow, will be more likely to heal the injured vasculature and go on to primary healing. Individuals with an inadequate mobilization of CAC's will fail to repair the damaged vasculature in the wound and proceed to necrosis and "conversion" to third degree, necrotic burn wounds.
- Conditions
- Wound Healing, Burns
- Being tested
- Healthy volunteers, Burn volunteers
- Keywords
- Wound Healing, Burns, HIF-1, CAC
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy volunteersGenetic
Comparison of healthy volunteers to burn wounded volunteers
Burn volunteersOther
Also called Burn wounds
Comparison of burn wounded volunteers to healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Burn volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 73 hours to 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: unable to recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Harmon, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796627
- Sponsor's protocol ID
- NA_00018037
- Status last verified
- Aug 2017
- First submitted
- 21 Nov 2008
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20231626
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIF-1 Regulated Circulating Angiogenic Cell Recruitment in Burn Wound Healing
- ClinicalTrials.gov ID
- NCT00796627
- Acronym / sponsor ID
- NA_00018037
- Conditions
- Wound Healing, Burns
- Keywords
- Wound Healing, Burns, HIF-1, CAC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit enough patients
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2006
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to increase knowledge about wound healing and different factors that may affect healing in burn patients.
Detailed description
Burn injuries represent a major public health problem, requiring medical attention for more than one million Americans annually. Despite therapeutic advances, non-healing burn wounds and excessive scarring still result in significant long term physical and psychosocial morbidity. In this study we propose to perform clinical and research to study the role of circulating angiogenic cells (CAC) in promoting burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of animal models of tissue injury ischemia and mobilization of CACs into the peripheral blood has been demonstrated in burn wound patients.
We hypothesize that primary healing of burn wounds is dependent on repair of damaged vasculature, and that bone marrow derived stem cells, circulating angiogenic cells (CAC), play a critical role in the healing process. Furthermore we propose that the transcription factor Hypoxia Inducible Factor 1 alpha (HIF 1 alpha) through production of peptide products of its downstream target genes directs the "homing" of CAC's to the wound where they participate in healing events. The first aim of this study is to correlate mobilization of CAC's into the blood stream with the success of burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of studies. The relationship between mobilization of CAC's and burn wound healing has not been examined. In addition to surveying CAC numbers in the peripheral blood, we will assay levels of the putative mediators of CAC mobilization: Vascular Endothelial Growth Factor (VEGF), Placenta Growth Factor (PLGF), and Stromal Cell-Derived Factor (SDF-1). We hypothesize that individuals who are able to mount a large and sustained mobilization of CAC's into the peripheral blood from the bone marrow, will be more likely to heal the injured vasculature and go on to primary healing. Individuals with an inadequate mobilization of CAC's will fail to repair the damaged vasculature in the wound and proceed to necrosis and "conversion" to third degree, necrotic burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Sham comparator | Genetic: Healthy volunteersHealthy 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. |
| Burn volunteer | Active comparator | Other: Burn volunteersTo 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 |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy volunteersComparison of healthy volunteers to burn wounded volunteers | Genetic | Healthy volunteers |
| Burn volunteersAlso: Burn woundsComparison of burn wounded volunteers to healthy volunteers | Other | Burn volunteer |
Primary outcome
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
Time frame: baseline
Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time frame: 0 to 24 hours post-operative
Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time frame: 49 to 72 hours post-operative
Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time frame: 73 hours to 6 weeks post-operative
Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20231626Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Harmon, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy volunteers and Burn volunteers in people with Wound Healing and Burns, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00796627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.