Ulcers in which the presence of meticillin resistant Staphylococcus aureus (MRSA) has been identified. MedDRA version: 9.1 Level: LLT Classification code 10045285 Term: Ulcer
Conditions
Interventions
Product Name: gaseous Nitric Oxide
Pharmaceutical Form:
Sponsors
Nitric BioTherapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject: - Must have given written informed consent - Must be 18 years of age or over and, if female, not of child bearing potential - Must have an ulcer in which the presence of MRSA has been positively identified but which is not clinically infected. - Must have an ulcer size not to extend beyond the inner borders of the dressing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject: -Is pregnant or a female who could become pregnant - Is < 18 years of age - Has a clinically infected ulcer - Has an ulcer that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment. - Is using systemic antibiotics or has been using systemic antibiotics during 7 days prior to enrolment into this study. - Has an ulcer which is identified as malignant in origin (e.g., Marjolin’s ulcer) - Has an ulcer size beyond the inner borders of the dressing - Is septic or has other signs of an invasive infection - Has used any 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 - Is immune deficient - Is using any of the prohibited concomitant medications or treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of topically applied gaseous nitric oxide to reduce microorganisms including MRSA. ;Secondary Objective: To determine the effect of the application of gaseous nitric oxide on the condition of the ulcer. To determine the safety of the treatment as measured by the incidence of adverse events.;Primary end point(s): A 3-Log (or better) reduction in microorganisms including MRSA. | — |
Countries
United Kingdom
Outcome results
None listed