Chronic Ulcer of Lower Extremity
Conditions
Keywords
chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers
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.
Interventions
DRUGNitric Oxide
Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
Sponsors
Nitric BioTherapeutics, Inc
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Endpoint Measure is a Reduction on Wound Size. | 28 days post enrollment | reduction in bioburden as assessed by number of cfu's per cm2 on culture |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Treatment | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Evidence of a colonized wound on the lower extremity. 18 to 65 years | 3 participants |
| Evidence of a colonized wound on the lower extremity. >=65 years | 4 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Time frame: at 28 days post enrollment
Population: Data not available for this study due to dissolution of company contracted to perform study analysis
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
Time frame: 28 days post enrollment
Population: Data not available for this study due to dissolution of company contracted to perform analysis.