Trial Outcomes & Findings for Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers (NCT NCT00545298)
NCT ID: NCT00545298
Last Updated: 2012-11-19
Results Overview
% Re-epithelialization
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Week 20
Results posted on
2012-11-19
Participant Flow
single site, 4 subjects recruited starting in October, 2007 with the last vist on August 28, 2008
Participant milestones
| Measure |
A - Standard of Care (Control)
Standard of care - dressings and sustained compression only
|
B - Same Treatment for 6 Weeks
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
|
C - Modified Treatment, 5 Wks Lower Dose
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
A - Standard of Care (Control)
Standard of care - dressings and sustained compression only
|
B - Same Treatment for 6 Weeks
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
|
C - Modified Treatment, 5 Wks Lower Dose
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
|---|---|---|---|
|
Overall Study
Issues with Standard of Care
|
2
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
Baseline characteristics by cohort
| Measure |
A - Standard of Care (Control)
n=2 Participants
Standard of care - dressings and sustained compression only
|
B Same Treatment for 6 Weeks
n=1 Participants
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
|
C - Modified Treatment, 5 Wks Lower Dose
n=1 Participants
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age Continuous
|
76 years
STANDARD_DEVIATION 4 • n=93 Participants
|
60 years
STANDARD_DEVIATION 0 • n=4 Participants
|
65 years
STANDARD_DEVIATION 0 • n=27 Participants
|
69 years
STANDARD_DEVIATION 5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
4 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 20Population: Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point
% Re-epithelialization
Outcome measures
| Measure |
B - Same Treatment for 6 Weeks
n=1 Participants
This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
|
A - Standard of Care (Control)
Standard of Care - dressings and sustained compression only
|
C - Modified Treatment, 5 Wks Lower Dose
200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
|---|---|---|---|
|
Wound Healing
|
10 % re-epithelialization
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 24 weeksPopulation: All enrolled subjects, 4 in total
All reported adverse events, related or unrelated to the study drug.
Outcome measures
| Measure |
B - Same Treatment for 6 Weeks
n=2 Participants
This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
|
A - Standard of Care (Control)
n=1 Participants
Standard of Care - dressings and sustained compression only
|
C - Modified Treatment, 5 Wks Lower Dose
n=1 Participants
200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
|---|---|---|---|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
4 number of events
|
4 number of events
|
7 number of events
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 number of events
|
0 number of events
|
0 number of events
|
Adverse Events
A - Standard of Care (Control)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
B Same Treatment for 6 Weeks
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
C - Modified Treatment, 5 Wks Lower Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A - Standard of Care (Control)
n=2 participants at risk
Standard of care - dressings and sustained compression only
|
B Same Treatment for 6 Weeks
n=1 participants at risk
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
|
C - Modified Treatment, 5 Wks Lower Dose
n=1 participants at risk
200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain/ Compression Wrap
|
50.0%
1/2 • Number of events 2 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/2 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
|
General disorders
epistaxis
|
0.00%
0/2 • up to 24 weeks
|
100.0%
1/1 • Number of events 2 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
blister formation
|
0.00%
0/2 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
deterioration of the wound
|
50.0%
1/2 • Number of events 1 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
100.0%
1/1 • Number of events 3 • up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
viral illness
|
0.00%
0/2 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
50.0%
1/2 • Number of events 1 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
wound infection
|
0.00%
0/2 • up to 24 weeks
|
0.00%
0/1 • up to 24 weeks
|
100.0%
1/1 • Number of events 1 • up to 24 weeks
|
Additional Information
Frank J. McCaney, CEO Sponsor
Nitric BioTherapeutics Inc
Phone: 215-788-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is only allowed to publish the results of the trial with the permission of the Sponsor
- Publication restrictions are in place
Restriction type: OTHER