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

NCT00613808 | Terminated Phase 2 DMC

• 1 other identifier: CTP 3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Ulcers

Keywords

venous; leg; ulcer

Outcome Measures

Primary Outcomes (1)

• Effect of daily application of Nitric Oxide on rate of closure in venous ulcers

  24 weeks or wound closure

Secondary Outcomes (2)

• Change in quality of life

  24 weeks or wound closure

• Incidence of adverse events

  24 weeks or wound closure

Study Arms (2)

A - Standard of Care (control)

NO INTERVENTION

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

B Same treatment for 6 weeks, 200ppm NO gas

ACTIVE COMPARATOR

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

Interventions

Nitric Oxide 200ppm Group B DRUG

200 ppm, 8hrs / day for 6 weeks

B Same treatment for 6 weeks, 200ppm NO gas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitric BioTherapeutics, Inc: lead

Study Sites (2)

Diabetic Foot & Wound Center

Denver, Colorado, 80220, United States

Location

Alamo Podiatry Associates

San Antonio, Texas, 78211, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Jensen, DPM

  Private Practice, Denver, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (2)