Venous UlcersPhase 2NCT00613808
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
A Phase 2 study testing Nitric Oxide 200ppm Group B in people with Venous Ulcers, run by Nitric BioTherapeutics, Inc at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg. 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 200ppm Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to May 2009
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent and HIPAA authorization
- Must be ≥ 18 years of age
- Must have a venous ulcer for 60 days or greater
- ABPI > 0.8 and ≤ 1.2
- Must have ulcer between 3cm2 and 25cm2 in size
Who cannot join
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- BMI ≥ 35
- Has evidence of clinical infection
- Suffers from diabetes mellitus with HbA1c ≥ 8%
- Suffers from clinically significant arterial disease
- Has a known allergy to any of the compounds / drugs that are part of this protocol
Show all 13Show fewer
- Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
- Has used any investigational drug(s) within 30 days preceding randomization
- Is unable to manage self-treatment
- Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
- Is using any of the prohibited concomitant medications or treatments
- Has previously participated in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Diabetic Foot & Wound Center
Denver, Colorado, 80220
Alamo Podiatry Associates
San Antonio, Texas, 78211
About this study
Official title: An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.
Read the detailed description
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.
- Conditions
- Venous Ulcers
- Being tested
- Nitric Oxide 200ppm Group B
- Keywords
- venous, leg, ulcer
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide 200ppm Group BDrug
200 ppm, 8hrs / day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| A - Standard of Care (control) | No intervention | Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter |
| B Same treatment for 6 weeks, 200ppm NO gas | Active comparator | Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks Receives: Drug: Nitric Oxide 200ppm Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
Measured: 24 weeks or wound closure
Secondary outcomes (2)
Change in quality of life
Measured: 24 weeks or wound closure
Incidence of adverse events
Measured: 24 weeks or wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Jensen, DPM, Principal investigator, Private Practice, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613808
- Sponsor's protocol ID
- CTP 3
- Status last verified
- Jan 2012
- First submitted
- 30 Jan 2008
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities
- ClinicalTrials.gov ID
- NCT00613808
- Acronym / sponsor ID
- CTP 3
- Conditions
- Venous Ulcers
- Keywords
- venous, leg, ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Feb 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 whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.
Detailed description
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Standard of Care (control) | No intervention | –Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter |
| B Same treatment for 6 weeks, 200ppm NO gas | Active comparator | Drug: Nitric Oxide 200ppm Group BSubjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have given written informed consent and HIPAA authorization
- Must be ≥ 18 years of age
- Must have a venous ulcer for 60 days or greater
- ABPI > 0.8 and ≤ 1.2
- Must have ulcer between 3cm2 and 25cm2 in size
Key exclusion criteria (13 listed)
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- BMI ≥ 35
- Has evidence of clinical infection
- Suffers from diabetes mellitus with HbA1c ≥ 8%
- Suffers from clinically significant arterial disease
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 200ppm Group B200 ppm, 8hrs / day for 6 weeks | Drug | B Same treatment for 6 weeks, 200ppm NO gas |
Primary outcome
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers
Time frame: 24 weeks or wound closure
2 secondary outcomes
Change in quality of life
Time frame: 24 weeks or wound closure
Incidence of adverse events
Time frame: 24 weeks or wound closure
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Jeffrey Jensen, DPM principal investigator
Private Practice, Denver, CO
2 sites 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 200ppm Group B in people with Venous Ulcers, run by Nitric BioTherapeutics, Inc at 2 sites 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 5 inclusion and 13 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 25 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 2 sites 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?
The study was stopped early. 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?
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers (time frame: 24 weeks or wound closure). 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 25 Jan 2012.