Venous UlcersPhase 2NCT00545298
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
A Phase 2 study testing Nitric Oxide - same dose 6 wks and Nitric Oxide modified treatment in people with Venous Ulcers, run by Nitric BioTherapeutics, Inc at 1 site in United States.
Trial summary
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- Nitric Oxide - same dose 6 wks and Nitric Oxide modified treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 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
- Must have a venous stasis ulcer between the knee and the ankle.
- Ulcer duration must be 60 days or greater
Who cannot join
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- Suffers from diabetes mellitus with HbA1c ≥ 8%
- Suffers from clinically significant arterial disease
- Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Retreat Hospital, Wound Healing Center
Richmond, Virginia, 23220
About this study
Official title: An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
Read the detailed description
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
- Conditions
- Venous Ulcers
- Being tested
- Nitric Oxide - same dose 6 wks, Nitric Oxide modified treatment
- Keywords
- Nitric Oxide, Venous Leg Ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide - same dose 6 wksDrug
200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
Nitric Oxide modified treatmentDrug
200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
| Study group | Role | What they receive |
|---|---|---|
| A - Standard of Care (control) | No intervention | Standard of care - dressings and sustained compression only |
| B Same treatment for 6 weeks | Experimental | 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound Receives: Drug: Nitric Oxide - same dose 6 wks |
| C - modified treatment, 5 wks lower dose | Experimental | 200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound Receives: Drug: Nitric Oxide modified treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
% Re-epithelialization
Measured: Week 20
Adverse Events (AEs) and Serious Adverse Events (SAEs)
All reported adverse events, related or unrelated to the study drug.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Strategic direction of the sponsor changed
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 Venous UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph V Boykin, MD, Principal investigator, HCA Retreat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545298
- Sponsor's protocol ID
- CTP 1
- Status last verified
- Oct 2012
- First submitted
- 16 Oct 2007
- Last updated
- 19 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Leg Ulcers of the Lower Extremities
- ClinicalTrials.gov ID
- NCT00545298
- Acronym / sponsor ID
- CTP 1
- Conditions
- Venous Ulcers
- Keywords
- Nitric Oxide, Venous Leg Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic direction of the sponsor changed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 19 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
Detailed description
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - Standard of Care (control) | No intervention | –Standard of care - dressings and sustained compression only |
| B Same treatment for 6 weeks | Experimental | Drug: Nitric Oxide - same dose 6 wks200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound |
| C - modified treatment, 5 wks lower dose | Experimental | Drug: Nitric Oxide modified treatment200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have a venous stasis ulcer between the knee and the ankle.
- Ulcer duration must be 60 days or greater
Key exclusion criteria (5 listed)
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- Suffers from diabetes mellitus with HbA1c ≥ 8%
- Suffers from clinically significant arterial disease
- Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)
- The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
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 Oxide - same dose 6 wks200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound | Drug | B Same treatment for 6 weeks |
| Nitric Oxide modified treatment200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound | Drug | C - modified treatment, 5 wks lower dose |
Primary outcome
Wound Healing
Time frame: Week 20
% Re-epithelialization
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 24 weeks
All reported adverse events, related or unrelated to the study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- 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.
Joseph V Boykin, MD principal investigator
HCA Retreat Hospital
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 - same dose 6 wks and Nitric Oxide modified treatment in people with Venous Ulcers, run by Nitric BioTherapeutics, Inc 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 5 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 Nov 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 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 19 Nov 2012). 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?
Wound Healing (time frame: Week 20). The study lists 2 primary outcomes in all. 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 Nov 2012.