Leg UlcerPhase 1/2NCT00771368
Reduction of Bacteria in MRSA Positive Ulcers
A Phase 1/2 study testing Nitric Oxide in people with Leg Ulcer and Pressure Ulcer, run by Nitric BioTherapeutics, Inc at 1 site in Canada.
Trial summary
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Leg Ulcer, Pressure Ulcer
- What is being tested?
- Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent
- Must be 19 years of age or over
- Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
- Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover
Who cannot join
- Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Is < 19 years of age
- Has a clinically infected ulcer
- Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
- Has been using systemic antibiotics during 7 days prior to enrolment into this study.
- Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
Show all 14Show fewer
- Has an Ulcer / Lesion size beyond the inner borders of the wound cover
- Is septic or has other signs of an invasive infection
- Has used any other investigational product within 30 days preceding study participation.
- Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety.
- Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.
- Has a known allergy to any of the products that are part of this protocol
- Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection.
- Is using any of the prohibited concomitant medications or treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers
- Conditions
- Leg Ulcer, Pressure Ulcer
- Being tested
- Nitric Oxide
- Medical subject headings
- Leg Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Experimental | gaseous nitric oxide delivered topically for 30 minutes Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bacteria
Measured: Post Treatment Day 3
Secondary outcomes (1)
Incidence of adverse events
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionJun 2009
Why it stopped: limited recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771368
- Sponsor's protocol ID
- CTP 7
- Status last verified
- Jan 2012
- First submitted
- 10 Oct 2008
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
- ClinicalTrials.gov ID
- NCT00771368
- Acronym / sponsor ID
- CTP 7
- Conditions
- Leg Ulcer, Pressure Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited recruitment
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | Experimental | Drug: Nitric Oxidegaseous nitric oxide delivered topically for 30 minutes |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have given written informed consent
- Must be 19 years of age or over
- Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
- Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover
Key exclusion criteria (14 listed)
- Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Is < 19 years of age
- Has a clinically infected ulcer
- Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
- Has been using systemic antibiotics during 7 days prior to enrolment into this study.
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 Oxide1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days | Drug | Nitric Oxide |
Primary outcome
Reduction in bacteria
Time frame: Post Treatment Day 3
1 secondary outcome
Incidence of adverse events
Time frame: 3 days
Results and safety
The study was stopped early (reason given: limited recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide in people with Leg Ulcer and Pressure Ulcer, run by Nitric BioTherapeutics, Inc at 1 site in Canada.
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 4 inclusion and 14 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 19 Jan 2012. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: limited recruitment). Results are not available in the source record.
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?
Reduction in bacteria (time frame: Post Treatment Day 3). 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 19 Jan 2012.