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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - Standard of Care (control)

Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter

Group Type NO_INTERVENTION

No interventions assigned to this group

B Same treatment for 6 weeks, 200ppm NO gas

Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks

Group Type ACTIVE_COMPARATOR

Nitric Oxide 200ppm Group B

Intervention Type DRUG

200 ppm, 8hrs / day for 6 weeks

Interventions

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Nitric Oxide 200ppm Group B

200 ppm, 8hrs / day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No