A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers (NOVEL2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01199588
First received: September 9, 2010
Last updated: April 29, 2014
Last verified: April 2014

September 9, 2010
April 29, 2014
May 2011
December 2012   (final data collection date for primary outcome measure)
Surface area reduction [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Time to complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01199588 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of complete closure [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Surface area reduction [ 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 ]
Not Provided
Not Provided
 
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Venous Leg Ulcers
  • Drug: Nexagon® Low Dose
    Weekly, topical application of Nexagon® low dose used with compression dressings.
  • Drug: Nexagon® High Dose
    Weekly, topical application of Nexagon® high dose used with compression dressings.
  • Drug: Nexagon® Vehicle
    Weekly, topical application of Nexagon® Vehicle used with compression dressings.
  • Experimental: Nexagon® High Dose
    Weekly applications of Nexagon® high dose in addition to compression dressings.
    Intervention: Drug: Nexagon® High Dose
  • Placebo Comparator: Nexagon® Vehicle
    Weekly applications of Nexagon® Vehicle in addition to compression dressings.
    Intervention: Drug: Nexagon® Vehicle
  • 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.
    Intervention: Drug: Nexagon® Low Dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   New Zealand,   South Africa
 
NCT01199588
NEX-ULC-007
Yes
CoDa Therapeutics Inc.
CoDa Therapeutics Inc.
Not Provided
Principal Investigator: Tom Serena, MD Penn North Centers For Advanced Wound Care, PA, USA
CoDa Therapeutics Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP