Venous Leg UlcersPhase 2NOVEL2NCT01199588
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
A Phase 2 study testing Nexagon® Low Dose and Nexagon® High Dose in people with Venous Leg Ulcers, run by OcuNexus Therapeutics, Inc. at 34 sites in 4 countries.
Trial summary
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- Nexagon® Low Dose and Nexagon® High Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 34 sitesin 4 countries
- Study dates
- May 2011to Mar 2013
- 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 supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
- Ankle brachial index of > 0.80
- Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
- Compliant with and able to tolerate high compression bandaging
- VLU present for > 30 days prior to study entry
- VLU is full thickness
- The subject is willing and able to give informed consent
Who cannot join
- Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
- More than 75% of the VLU is on or below the malleolus
- Presence of a non-study ulcer within 1.5 cm of the VLU
- A VLU which shows signs of clinical infection or has cellulitis
- The VLU wound bed has exposed bone, tendon or fascia
- BMI > 45.0 kg/m2
Show all 14Show fewer
- Subject is not ambulatory
- Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study
- Cancerous cells in the VLU
- HbA1c >10%
- Blood biochemistry >3x upper limit of normal
- Heart failure NYHA class III or IV
- Subjects on renal replacement therapy
- Immunocompromized subjects
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States21 sites
Bay Area Foot Care
Castro Valley, California, 94546
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
UT Southwestern Medical Center
Dallas, Texas, 75235
Saint Paul's Women's Center
Dallas, Texas, 75237
Diabetic Foot & Wound Treatment Center
El Centro, California, 92243
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, 16544
Advanced Foot Care and Clinical Research Center
Fresno, California, 93722
Passavant Area Hospital
Jacksonville, Illinois, 62650
Penn North Center For Advanced Wound Care
Kittaning, Pennsylvania, 16544
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
St Luke's - Roosevelt Hospital Center Department of Surgery
New York, New York, 10025
Stonybrook Univeristy Medical Center
New York, New York, 11794
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, 85015
DRMC Wound Clinic
Saint Geroge, Utah, 84770
Doctor's Research Network
South Miami, Florida, 33143
South Florida Wound Care Group
Tamarac, Florida, 33321
Oceana Country Foot and Ankle
Toms River, New Jersey, 08753
Aung Foot Health Clinics
Tucson, Arizona, 85710
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, 85724
St. John Wound Center
Tulsa, Oklahoma, 74135
Center For Advanced Wound Care
Wyomissing, Pennsylvania, 19610
South Africa9 sites
Josha Research
Bloemfontein, 9301
Boland Ethical Research Group
Cape Town, 6850
Randles Road Medical Centre
Durban, 4091
Dr D. Lakha
Johannesburg, Gauteng, 1829
Unitas Hospital
Johannesburg, 0157
WorthwhileClinical Trials
Johannesburg, 1500
Sunninghill Hospital
Johannesburg, 2157
Witwatersrand University Medical School
Johannesburg, 2193
GCT Mercantile Clinical Trial Centre
Port Elizabeth, 6020
Australia2 sites
Heidelberg Repatriation Hospital
Melbourne, Victoria
South Sydney Vascular Centre
Sydney, New South Wales, 2228
New Zealand2 sites
Dunedin Hospital
Dunedin, Otago
Awhinatina Health
Manukau, Auckland, 2110
About this study
Official title: A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon® in the Treatment of Subjects With a Venous Leg Ulcer
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
- Conditions
- Venous Leg Ulcers
- Being tested
- Nexagon® Low Dose, Nexagon® High Dose, Nexagon® Vehicle
- Keywords
- VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa
- Medical subject headings
- Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexagon® Low DoseDrug
Weekly, topical application of Nexagon® low dose used with compression dressings.
Nexagon® High DoseDrug
Weekly, topical application of Nexagon® high dose used with compression dressings.
Nexagon® VehicleDrug
Weekly, topical application of Nexagon® Vehicle used with compression dressings.
| Study group | Role | What they receive |
|---|---|---|
| Nexagon® High Dose | Experimental | Weekly applications of Nexagon® high dose in addition to compression dressings. Receives: Drug: Nexagon® High Dose |
| Nexagon® Vehicle | Placebo comparator | Weekly applications of Nexagon® Vehicle in addition to compression dressings. Receives: Drug: Nexagon® Vehicle |
| No Investigational Product | No intervention | Weekly application of compression dressings. |
| Nexagon® Low Dose | Experimental | Weekly applications of Nexagon® low dose in addition to compression dressings. Receives: Drug: Nexagon® Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface area reduction
Measured: 10 weeks
Secondary outcomes (5)
Incidence of complete closure
Measured: 10 weeks
Time to complete closure
Measured: 10 weeks
Incidence of ulcer recurrence
Measured: 12 weeks post closure
Pain
Measured: 10 weeks
Incidence of adverse events
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuNexus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Serena, MD, Principal investigator, Penn North Centers For Advanced Wound Care, PA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199588
- Sponsor's protocol ID
- NEX-ULC-007
- Acronym
- NOVEL2
- Status last verified
- Apr 2014
- First submitted
- 9 Sep 2010
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Dose-Ranging, Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nexagon® in the Treatment of Subjects With a Venous Leg Ulcer
- ClinicalTrials.gov ID
- NCT01199588
- Acronym / sponsor ID
- NOVEL2 / NEX-ULC-007
- Conditions
- Venous Leg Ulcers
- Keywords
- VLU, Venous Leg Ulcers, Ulcers, chronic wounds, wounds, Nexagon, CoDa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- OcuNexus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2010 (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.
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nexagon® High Dose | Experimental | Drug: Nexagon® High DoseWeekly applications of Nexagon® high dose in addition to compression dressings. |
| Nexagon® Vehicle | Placebo comparator | Drug: Nexagon® VehicleWeekly applications of Nexagon® Vehicle in addition to compression dressings. |
| No Investigational Product | No intervention | –Weekly application of compression dressings. |
| Nexagon® Low Dose | Experimental | Drug: Nexagon® Low DoseWeekly applications of Nexagon® low dose in addition to compression dressings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
- Ankle brachial index of > 0.80
- Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
- Compliant with and able to tolerate high compression bandaging
- VLU present for > 30 days prior to study entry
Key exclusion criteria (14 listed)
- Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
- More than 75% of the VLU is on or below the malleolus
- Presence of a non-study ulcer within 1.5 cm of the VLU
- A VLU which shows signs of clinical infection or has cellulitis
- The VLU wound bed has exposed bone, tendon or fascia
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® Low DoseWeekly, topical application of Nexagon® low dose used with compression dressings. | Drug | Nexagon® Low Dose |
| Nexagon® High DoseWeekly, topical application of Nexagon® high dose used with compression dressings. | Drug | Nexagon® High Dose |
| Nexagon® VehicleWeekly, topical application of Nexagon® Vehicle used with compression dressings. | Drug | Nexagon® Vehicle |
Primary outcome
Surface area reduction
Time frame: 10 weeks
5 secondary outcomes
Incidence of complete closure
Time frame: 10 weeks
Time to complete closure
Time frame: 10 weeks
Incidence of ulcer recurrence
Time frame: 12 weeks post closure
Pain
Time frame: 10 weeks
Incidence of adverse events
Time frame: 10 weeks
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 1 May 2014.
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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.
Tom Serena, MD principal investigator
Penn North Centers For Advanced Wound Care, PA, USA
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nexagon® Low Dose and Nexagon® High Dose in people with Venous Leg Ulcers, run by OcuNexus Therapeutics, Inc. at 34 sites in 4 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 7 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: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, South Africa, Australia, New Zealand. 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. Some participants in this study may receive a placebo. 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?
Surface area reduction (time frame: 10 weeks). 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 1 May 2014.