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
  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:


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
Study Completion Date: March 2013
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199588

  Hide Study Locations
Locations
United States, Arizona
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, United States, 85015
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, United States, 85724
Aung Foot Health Clinics
Tucson, Arizona, United States, 85710
United States, California
Bay Area Foot Care
Castro Valley, California, United States, 94546
Diabetic Foot & Wound Treatment Center
El Centro, California, United States, 92243
Advanced Foot Care and Clinical Research Center
Fresno, California, United States, 93722
United States, Florida
Doctor's Research Network
South Miami, Florida, United States, 33143
South Florida Wound Care Group
Tamarac, Florida, United States, 33321
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Passavant Area Hospital
Jacksonville, Illinois, United States, 62650
United States, Nevada
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Oceana Country Foot and Ankle
Toms River, New Jersey, United States, 08753
United States, New York
St Luke's - Roosevelt Hospital Center Department of Surgery
New York, New York, United States, 10025
Stonybrook Univeristy Medical Center
New York, New York, United States, 11794
United States, Oklahoma
St. John Wound Center
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Penn North Center For Advanced Wound Care
Erie, Pennsylvania, United States, 16544
Penn North Center For Advanced Wound Care
Kittaning, Pennsylvania, United States, 16544
Center For Advanced Wound Care
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Saint Paul's Women's Center
Dallas, Texas, United States, 75237
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
United States, Utah
DRMC Wound Clinic
St. Geroge, Utah, United States, 84770
Australia, New South Wales
South Sydney Vascular Centre
Sydney, New South Wales, Australia, 2228
Australia, Victoria
Heidelberg Repatriation Hospital
Melbourne, Victoria, Australia
New Zealand
Awhinatina Health
Manukau, Auckland, New Zealand, 2110
Dunedin Hospital
Dunedin, Otago, New Zealand
South Africa
Dr D. Lakha
Johannesburg, Gauteng, South Africa, 1829
Josha Research
Bloemfontein, South Africa, 9301
Boland Ethical Research Group
Cape Town, South Africa, 6850
Randles Road Medical Centre
Durban, South Africa, 4091
WorthwhileClinical Trials
Johannesburg, South Africa, 1500
Unitas Hospital
Johannesburg, South Africa, 0157
Witwatersrand University Medical School
Johannesburg, South Africa, 2193
Sunninghill Hospital
Johannesburg, South Africa, 2157
GCT Mercantile Clinical Trial Centre
Port Elizabeth, South Africa, 6020
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: April 29, 2014
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 August 01, 2014