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

An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00613808

Enrollment

Registered

2008-02-13

Start date

2008-02-29

Completion date

2009-05-31

Last updated

2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcers

Keywords

venous, leg, ulcer

Brief summary

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.

Detailed 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.

Interventions

DRUGNitric Oxide 200ppm Group B

200 ppm, 8hrs / day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers	24 weeks or wound closure

Secondary

Measure	Time frame
Change in quality of life	24 weeks or wound closure
Incidence of adverse events	24 weeks or wound closure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026