Trial Outcomes & Findings for Hypoxia-inducible Factor-1 (HIF-1) Regulated Circulating Angiogenic Cells (CACs) Recruitment in Burn Wound Healing (NCT NCT00796627)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

baseline

Results posted on

2017-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Volunteers Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers
Overall Study STARTED	10	31
Overall Study COMPLETED	10	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=10 Participants Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer n=31 Participants Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers	Total n=41 Participants Total of all reporting groups
Age, Customized >=14, <=75	10 Participants n=10 Participants	31 Participants n=31 Participants	41 Participants n=41 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	7 Participants n=31 Participants	10 Participants n=41 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	24 Participants n=31 Participants	31 Participants n=41 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	31 participants n=31 Participants	41 participants n=41 Participants

PRIMARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=10 Participants Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer n=31 Participants Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers
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	4,000 cells per standard well Interval 3500.0 to 4500.0	6,500 cells per standard well Interval 6000.0 to 7000.0

PRIMARY outcome

Timeframe: 0 to 24 hours post-operative

Population: Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.

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

Outcome measures

Outcome measures
Measure	Healthy Volunteers Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer n=31 Participants Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury	—	6500 cells per standard well Interval 6000.0 to 7000.0

PRIMARY outcome

Timeframe: 49 to 72 hours post-operative

Population: Data only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.

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

Outcome measures

Outcome measures
Measure	Healthy Volunteers Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer n=31 Participants Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury	—	5000 cells per standard well Interval 4000.0 to 6000.0

PRIMARY outcome

Timeframe: 73 hours to 6 weeks post-operative

Population: Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.

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

Outcome measures

Outcome measures
Measure	Healthy Volunteers Healthy volunteers with no burn wounds Healthy volunteers: Comparison of healthy volunteers to burn wounded volunteers	Burn Volunteer n=31 Participants Burn wounded volunteers Burn volunteers: Comparison of burn wounded volunteers to healthy volunteers
Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury	—	3500 cells per standard well Interval 3000.0 to 4000.0

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Burn Volunteer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Harmon

Johns Hopkins University

Phone: 410-550-0405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place