Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

NCT ID: NCT00823095

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-10-31

Brief 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.

Detailed 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.

Conditions

Chronic Ulcer of Lower Extremity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topically applied Nitric Oxide

Topically applied Nitric Oxide for 8 hours daily for 2 weeks.

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

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

Interventions

Nitric Oxide

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

Intervention Type: DRUG

Other Intervention Names

ViaNOx-H; gaseous nitric oxide; gNO

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nitric BioTherapeutics, Inc

INDUSTRY

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takkin Lo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

DMF 15551

Identifier Type: -

Identifier Source: secondary_id

IND 68617

Identifier Type: -

Identifier Source: secondary_id

TNO-1B

Identifier Type: -

Identifier Source: org_study_id