Venous UlcerPhase 2NCT00820196
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
A Phase 2 study testing Nexagon® in people with Venous Ulcer, run by OcuNexus Therapeutics, Inc. at 10 sites in 2 countries.
Trial summary
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Nexagon®
- How many people
- 98 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2009to May 2010
- 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
- Diagnosis of venous leg ulceration
- Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit.
- Reference ulcer area greater than 1 cm2 and less than 25 cm2
- Reference ulcer present for at least 4 weeks
- Have an ankle circumference of greater than 18 cm
- Male of female patients aged 18 years or over
Show all 10Show fewer
- Able to tolerate effective compression bandaging
- Patients able to walk independently with or without mobility aids
- Able and willing to give informed consent
- Able and willing to attend all follow up visits
Who cannot join
- Significant change in ulcer size in the screening period screening period
- Presence of a non-study ulcer within 2.0 cm of the reference ulcer
- Wound bed with exposed bone, tendon or fascia
- Patients with leg ulceration etiology other than venous insufficiency
- Patients who require wheel chairs for normal mobility
- Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
Show all 30Show fewer
- Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture.
- Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
- Female patients who are pregnant or breastfeeding.
- Patients who are currently taking:
- Pentoxifylline (Trental®)
- Immunosuppressive therapy
- Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
- Growth factors (e.g. Regranex)
- Cell cultures or topical skin factors
- Patients with:
- Renal insufficiency defined as an estimated GFR which is < 30 mL/min/1.7m2
- Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
- Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
- HbA1c > 8.5%
- Hemoglobin < 10 g/dL
- Hematocrit < 0.30
- Platelet count < 100,000
- Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris
- Patients with:
- Collagen vascular disease
- Severe rheumatoid arthritis
- Cellulitis or osteomyelitis
- Patients who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment
- Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, e.g., known to abuse alcohol or drugs currently or to have psychological disorders that could affect follow-up care
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
New Zealand6 sites
Waitemata District Health Board
Auckland, Auckland
District Nursing and Leg Ulcer Service A+Links Home Health
Auckland
Home Health Services Papakura
Auckland
Nurse Maude
Christchurch
Dunedin Hosptial
Dunedin
Waikato Hospital
Hamilton
United States4 sites
Penn North Centers for Advanced Wound Care
Erie, Pennsylvania, 16544
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Centre for Clinical Research
San Francisco, California, 94546
Pacific Wound Center
Stockton, California, 95204
About this study
Official title: A Randomized, Double-Blind, Vehicle-controlled, Parallel Group, Dose-Ranging, Multi-center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
- Conditions
- Venous Ulcer
- Being tested
- Nexagon®, Nexagon® vehicle
- Keywords
- Venous ulcer, Nexagon, CoDa
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon®Drug
Nexagon® vehicleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry
Secondary outcomes (3)
Complete healing of the treated Venous Leg Ulcer
Reference ulcer wound healing as assessed by digital photographic planimetry
Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- OcuNexus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Bannan, Study director, OcuNexus Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820196
- Sponsor's protocol ID
- NEX-ULC-001
- Status last verified
- Sep 2012
- First submitted
- 8 Jan 2009
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-controlled, Parallel Group, Dose-Ranging, Multi-center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT00820196
- Acronym / sponsor ID
- NEX-ULC-001
- Conditions
- Venous Ulcer
- Keywords
- Venous ulcer, Nexagon, CoDa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- OcuNexus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Jan 2009 (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.
Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of venous leg ulceration
- Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit.
- Reference ulcer area greater than 1 cm2 and less than 25 cm2
- Reference ulcer present for at least 4 weeks
- Have an ankle circumference of greater than 18 cm
Key exclusion criteria (30 listed)
- Significant change in ulcer size in the screening period screening period
- Presence of a non-study ulcer within 2.0 cm of the reference ulcer
- Wound bed with exposed bone, tendon or fascia
- Patients with leg ulceration etiology other than venous insufficiency
- Patients who require wheel chairs for normal mobility
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 |
|---|---|---|
| Nexagon® | Drug | – |
| Nexagon® vehicle | Drug | – |
Primary outcome
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry
3 secondary outcomes
Complete healing of the treated Venous Leg Ulcer
Reference ulcer wound healing as assessed by digital photographic planimetry
Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
Related trials for Venous Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
Scott Bannan study director
OcuNexus Therapeutics, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexagon® in people with Venous Ulcer, run by OcuNexus Therapeutics, Inc. at 10 sites in 2 countries.
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 10 inclusion and 30 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: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in New Zealand, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry. 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 18 Sep 2012.