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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01199588
First received: September 9, 2010
Last updated: September 16, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Venous Leg Ulcers
 Drug: Nexagon® Low Dose
Drug: Nexagon® High Dose
Drug: Nexagon® Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:
  • Surface area reduction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Time to complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Incidence of ulcer recurrence [ Time Frame: 12 weeks post closure ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199588

  Show 34 Study Locations
Sponsors and Collaborators
CoDa Therapeutics Inc.
Investigators
Principal Investigator: Tom Serena, MD Penn North Centers For Advanced Wound Care, PA, USA
  More Information

No publications provided

Responsible Party: CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01199588     History of Changes
Other Study ID Numbers: NEX-ULC-007
Study First Received: September 9, 2010
Last Updated: September 16, 2012
Health Authority: United States: Food and Drug Administration
New Zealand: Medsafe
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CoDa Therapeutics Inc.:
VLU
Venous Leg Ulcers
Ulcers
chronic wounds
 wounds
Nexagon
CoDa

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
 Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013