Reduction of Bacteria in MRSA Positive Ulcers

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nitric BioTherapeutics, Inc
• Treatments: Nitric Oxide

Criteria

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