Leg Ulcer, Pressure Ulcer
Conditions
Brief summary
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers
Interventions
DRUGNitric Oxide
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days
Sponsors
Nitric BioTherapeutics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have given written informed consent * Must be 19 years of age or over * Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected. * Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover
Exclusion criteria
* Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence) * Is \< 19 years of age * Has a clinically infected ulcer * Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment. * Has been using systemic antibiotics during 7 days prior to enrolment into this study. * Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer) * Has an Ulcer / Lesion size beyond the inner borders of the wound cover * Is septic or has other signs of an invasive infection * Has used any other investigational product within 30 days preceding study participation. * Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety. * Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data. * Has a known allergy to any of the products that are part of this protocol * Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection. * Is using any of the prohibited concomitant medications or treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in bacteria | Post Treatment Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 3 days |
Countries
Canada
Outcome results
None listed