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

Sponsor

Nitric BioTherapeutics, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT00613808

Collaborator

(none)

Enrollment

Locations

Arms

14.9

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Ulcers	Drug: Nitric Oxide 200ppm Group B	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
Active Comparator: 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	Drug: Nitric Oxide 200ppm Group B 200 ppm, 8hrs / day for 6 weeks

Arm

Intervention/Treatment

No Intervention: 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

Active Comparator: 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

Drug: Nitric Oxide 200ppm Group B

200 ppm, 8hrs / day for 6 weeks

Outcome Measures

Primary Outcome Measures

Effect of daily application of Nitric Oxide on rate of closure in venous ulcers [24 weeks or wound closure]

Secondary Outcome Measures

Change in quality of life [24 weeks or wound closure]
Incidence of adverse events [24 weeks or wound closure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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