A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)
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|ClinicalTrials.gov Identifier: NCT01199588|
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : May 1, 2014
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 ]
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|