Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Chronic Ulcer of Lower Extremity Clinical Trial

Official title:

The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823095
• Other study ID #: TNO-1B
• Secondary ID: DMF 15551IND 686
• Status: Terminated
• Phase: Phase 2
• First received: January 13, 2009
• Last updated: January 28, 2016
• Start date: December 2005
• Est. completion date: October 2008

Study information

• Verified date: April 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

Description:

The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:

• Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.

• Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).

• Tabulation of the number and types of adverse events during ViaNOx-H treatment.

• Comparisons of the response of different organisms to ViaNOx-H treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.

• Are 18 years of age or older.

Exclusion Criteria:

• Have had a change in their topical treatment during the last 4 weeks

• Have evidence of Clinical Infection

• Have a transcutaneous oxygen tension <30mmHg

• Have evidence of the ulcer or infection extending to the underlying muscle or bone.

• Are pregnant.

• Are less than 18 years of age.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Ulcer of Lower Extremity
• Leg Ulcer
• Skin Ulcer

Intervention

Drug:
• Nitric Oxide
Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to = +2.		at 28 days post enrollment	No
Secondary	The Secondary Endpoint Measure is a Reduction on Wound Size.	reduction in bioburden as assessed by number of cfu's per cm2 on culture	28 days post enrollment	No