Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

Nitric BioTherapeutics

Status and phase

Terminated

Phase 2

Conditions

Venous Ulcers

Treatments

Drug: Nitric Oxide 200ppm Group B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00613808

CTP 3

Details and patient eligibility

About

The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

Full description

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Has previously participated in this study