Reduction of Bacteria in MRSA Positive Ulcers

Nitric BioTherapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Pressure Ulcer

Leg Ulcer

Treatments

Drug: Nitric Oxide

Study type

Interventional

Funder types

Industry

Identifiers

CTP 7

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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