Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Loma Linda University (LLU)

Status and phase

Terminated

Phase 2

Conditions

Chronic Ulcer of Lower Extremity

Treatments

Drug: Nitric Oxide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00823095

DMF 15551

TNO-1B

IND 68617

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.