A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01199588 |
Recruitment Status :
Completed
First Posted : September 13, 2010
Last Update Posted : May 1, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Leg Ulcers | Drug: Nexagon® Low Dose Drug: Nexagon® High Dose Drug: Nexagon® Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Nexagon® High Dose
Weekly applications of Nexagon® high dose in addition to compression dressings.
|
Drug: Nexagon® High Dose
Weekly, topical application of Nexagon® high dose used with compression dressings. |
Placebo Comparator: Nexagon® Vehicle
Weekly applications of Nexagon® Vehicle in addition to compression dressings.
|
Drug: Nexagon® Vehicle
Weekly, topical application of Nexagon® Vehicle used with compression dressings. |
No Intervention: No Investigational Product
Weekly application of compression dressings.
|
|
Experimental: Nexagon® Low Dose
Weekly applications of Nexagon® low dose in addition to compression dressings.
|
Drug: Nexagon® Low Dose
Weekly, topical application of Nexagon® low dose used with compression dressings. |
- Surface area reduction [ Time Frame: 10 weeks ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199588

Principal Investigator: | Tom Serena, MD | Penn North Centers For Advanced Wound Care, PA, USA |
Responsible Party: | OcuNexus Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01199588 |
Other Study ID Numbers: |
NEX-ULC-007 |
First Posted: | September 13, 2010 Key Record Dates |
Last Update Posted: | May 1, 2014 |
Last Verified: | April 2014 |
VLU Venous Leg Ulcers Ulcers chronic wounds |
wounds Nexagon CoDa |
Varicose Ulcer Leg Ulcer Ulcer Pathologic Processes Skin Ulcer |
Skin Diseases Varicose Veins Vascular Diseases Cardiovascular Diseases |