Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nitric BioTherapeutics, Inc
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have given written informed consent and HIPAA authorization
Must be ≥ 18 years of age
Must have a venous ulcer for 60 days or greater
ABPI \> 0.8 and ≤ 1.2
Must have ulcer between 3cm2 and 25cm2 in size
You may not be if
Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
BMI ≥ 35
Has evidence of clinical infection
Suffers from diabetes mellitus with HbA1c ≥ 8%
Suffers from clinically significant arterial disease
Has a known allergy to any of the compounds / drugs that are part of this protocol
Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
Has used any investigational drug(s) within 30 days preceding randomization
Is unable to manage self-treatment
Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
Is using any of the prohibited concomitant medications or treatments
