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

Venous Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00613808
• Other study ID #: CTP 3
• Status: Terminated
• Phase: Phase 2
• First received: January 30, 2008
• Last updated: January 24, 2012
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: January 2012
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Ulcers

Intervention

Drug:
• Nitric Oxide 200ppm Group B
200 ppm, 8hrs / day for 6 weeks

Locations

Country	Name	City	State
United States	Diabetic Foot & Wound Center	Denver	Colorado
United States	Alamo Podiatry Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of daily application of Nitric Oxide on rate of closure in venous ulcers		24 weeks or wound closure	No
Secondary	Change in quality of life		24 weeks or wound closure	No
Secondary	Incidence of adverse events		24 weeks or wound closure	Yes