Chronic Ulcer of Lower ExtremityPhase 2NCT00823095
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
A Phase 2 study testing Nitric Oxide in people with Chronic Ulcer of Lower Extremity, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcer of Lower Extremity
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
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
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.
Read the 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
- Being tested
- Nitric Oxide
- Keywords
- chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called ViaNOx-H, gaseous nitric oxide, gNO
Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
| Study group | Role | What they receive |
|---|---|---|
| Topically applied Nitric Oxide | Experimental | Topically applied Nitric Oxide for 8 hours daily for 2 weeks. Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Measured: at 28 days post enrollment
Secondary outcomes (1)
The Secondary Endpoint Measure is a Reduction on Wound Size.
reduction in bioburden as assessed by number of cfu's per cm2 on culture
Measured: 28 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startDec 2005
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Subject recuitment halted and won't resume; subjects are no longer being treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Ulcer of Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Nitric BioTherapeutics, Inc
- Responsible party
- Sponsor
- Investigators
- Takkin Lo, MD, MPH, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823095
- Sponsor's protocol ID
- TNO-1B
- Other IDs
- DMF 15551, IND 68617
- Status last verified
- Apr 2014
- First submitted
- 13 Jan 2009
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00823095
- Acronym / sponsor ID
- TNO-1B
- Conditions
- Chronic Ulcer of Lower Extremity
- Keywords
- chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recuitment halted and won't resume; subjects are no longer being treated.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Nitric BioTherapeutics, Inc
- Study start
- Dec 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topically applied Nitric Oxide | Experimental | Drug: Nitric OxideTopically applied Nitric Oxide for 8 hours daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: ViaNOx-H, gaseous nitric oxide, gNOTopically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights. | Drug | Topically applied Nitric Oxide |
Primary outcome
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
1 secondary outcome
The Secondary Endpoint Measure is a Reduction on Wound Size.
Time frame: 28 days post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takkin Lo, MD, MPH principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide in people with Chronic Ulcer of Lower Extremity, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.