Status:
TERMINATED
Reduction of Bacteria in MRSA Positive Ulcers
Lead Sponsor:
Nitric BioTherapeutics, Inc
Conditions:
Leg Ulcer
Pressure Ulcer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00771368
Start Date
January 1 2009
End Date
June 1 2009
Last Update
January 19 2012
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9