Venous Ulcers
Conditions
Keywords
Nitric Oxide, Venous Leg Ulcers
Brief summary
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
Detailed description
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
Interventions
DRUGNitric Oxide - same dose 6 wks
200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
DRUGNitric Oxide modified treatment
200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
Sponsors
Nitric BioTherapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a venous stasis ulcer between the knee and the ankle. * Ulcer duration must be 60 days or greater
Exclusion criteria
* Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency * Suffers from diabetes mellitus with HbA1c ≥ 8% * Suffers from clinically significant arterial disease * Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent) The above is a partial list of the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | Week 20 | % Re-epithelialization |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 24 weeks | All reported adverse events, related or unrelated to the study drug. |
Countries
United States
Participant flow
Recruitment details
single site, 4 subjects recruited starting in October, 2007 with the last vist on August 28, 2008
Participants by arm
| Arm | Count |
|---|---|
| A - Standard of Care (Control) Standard of care - dressings and sustained compression only | 2 |
| 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 | 1 |
| 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 | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Issues with Standard of Care | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose | A - Standard of Care (Control) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 0 | 65 years STANDARD_DEVIATION 0 | 76 years STANDARD_DEVIATION 4 | 69 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Adverse Events (AEs) and Serious Adverse Events (SAEs)
All reported adverse events, related or unrelated to the study drug.
Time frame: up to 24 weeks
Population: All enrolled subjects, 4 in total
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B - Same Treatment for 6 Weeks | Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 number of events |
| B - Same Treatment for 6 Weeks | Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 number of events |
| A - Standard of Care (Control) | Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 number of events |
| A - Standard of Care (Control) | Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 number of events |
| C - Modified Treatment, 5 Wks Lower Dose | Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 number of events |
| C - Modified Treatment, 5 Wks Lower Dose | Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 number of events |
Primary
Wound Healing
% Re-epithelialization
Time frame: Week 20
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| B - Same Treatment for 6 Weeks | Wound Healing | 10 % re-epithelialization |