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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
Sponsor:
Information provided by (Responsible Party):
OcuNexus Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcers Drug: Nexagon® Low Dose Drug: Nexagon® High Dose Drug: Nexagon® Vehicle Phase 2

Study Design
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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

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Surface area reduction [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Incidence of complete closure [ Time Frame: 10 weeks ]
  2. Time to complete closure [ Time Frame: 10 weeks ]
  3. Incidence of ulcer recurrence [ Time Frame: 12 weeks post closure ]
  4. Pain [ Time Frame: 10 weeks ]
  5. Incidence of adverse events [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux > 0.5 seconds
  2. Ankle brachial index of > 0.80
  3. Venous Leg Ulcer (VLU) area greater than 2 cm2 and less than 20 cm2
  4. Compliant with and able to tolerate high compression bandaging
  5. VLU present for > 30 days prior to study entry
  6. VLU is full thickness
  7. The subject is willing and able to give informed consent

Exclusion Criteria:

  1. Decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period
  2. More than 75% of the VLU is on or below the malleolus
  3. Presence of a non-study ulcer within 1.5 cm of the VLU
  4. A VLU which shows signs of clinical infection or has cellulitis
  5. The VLU wound bed has exposed bone, tendon or fascia
  6. BMI > 45.0 kg/m2
  7. Subject is not ambulatory
  8. 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
  9. Cancerous cells in the VLU
  10. HbA1c >10%
  11. Blood biochemistry >3x upper limit of normal
  12. Heart failure NYHA class III or IV
  13. Subjects on renal replacement therapy
  14. Immunocompromized subjects
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
OcuNexus Therapeutics, Inc.
Investigators
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Principal Investigator: Tom Serena, MD Penn North Centers For Advanced Wound Care, PA, USA
More Information
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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
Keywords provided by OcuNexus Therapeutics, Inc.:
VLU
Venous Leg Ulcers
Ulcers
chronic wounds
 wounds
Nexagon
CoDa
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
 Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases