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A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
This study is not yet open for participant recruitment.
Verified by CoDa Therapeutics Inc., January 2009
Sponsored by: CoDa Therapeutics Inc.
Information provided by: CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00820196
  Purpose

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.


Condition Intervention Phase
Venous Ulcer
Drug: Nexagon®
Drug: Nexagon® vehicle
Phase II

MedlinePlus related topics: Leg Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose-Ranging, Multi-Center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers

Further study details as provided by CoDa Therapeutics Inc.:

Primary Outcome Measures:
  • Rate of reduction in the size of the reference ulcer from Day 0 to Day 28 as measured by photographic planimetry

Secondary Outcome Measures:
  • Incidence of adverse events
  • Reference ulcer wound healing as assessed by digital photographic planimetry
  • Pain

Estimated Enrollment: 90
Study Start Date: February 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  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
  2. Ankle brachial index of > 0.80 measured during screening or within three months prior to the Day -14 visit.
  3. Reference ulcer area greater than 1 cm2 and less than 25 cm2
  4. Reference ulcer present for at least 4 weeks
  5. Have an ankle circumference of greater than 18 cm
  6. Male of female patients aged 18 years or over
  7. Able to tolerate effective compression bandaging
  8. Patients able to walk independently with or without mobility aids
  9. Able and willing to give informed consent
  10. Able and willing to attend all follow up visits

Exclusion Criteria:

  1. Significant change in ulcer size in the screening period screening period
  2. Presence of a non-study ulcer within 2.0 cm of the reference ulcer
  3. Wound bed with exposed bone, tendon or fascia
  4. Patients with leg ulceration etiology other than venous insufficiency
  5. Patients who require wheel chairs for normal mobility
  6. Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
  7. Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture.
  8. Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
  9. Female patients who are pregnant or breastfeeding.
  10. Patients who are currently taking:

    1. Pentoxifylline (Trental®)
    2. Immunosuppressive therapy
    3. Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
    4. Growth factors (e.g. Regranex)
    5. Cell cultures or topical skin factors
  11. Patients with:

    1. Renal insufficiency defined as an estimated GFR which is < 30 mL/min/1.7m2
    2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
    3. Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
    4. HbA1c > 8.5%
    5. Hemoglobin < 10 g/dL
    6. Hematocrit < 0.30
    7. Platelet count < 100,000
  12. Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris
  13. Patients with:

    1. Collagen vascular disease
    2. Severe rheumatoid arthritis
    3. Cellulitis or osteomyelitis
  14. Patients who have, or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment
  15. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, e.g., known to abuse alcohol or drugs currently or to have psychological disorders that could affect follow-up care
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820196

Contacts
Contact: Andrew Jull, PhD (09) 373 7599 ext 84744 a.jull@ctru.auckland.ac.nz
Contact: Elizabeth Glen (09) 373 7599 ext 84662 e.glen@ctru.auckland.ac.nz

Sponsors and Collaborators
CoDa Therapeutics Inc.
Investigators
Principal Investigator: Andrew Jull, PhD Clinical Trials Research Organization
  More Information

Responsible Party: CoDa Therapeutics ( Scott Bannan )
Study ID Numbers: NEX-ULC-001
Study First Received: January 8, 2009
Last Updated: January 11, 2009
ClinicalTrials.gov Identifier: NCT00820196  
Health Authority: New Zealand: Medsafe

Keywords provided by CoDa Therapeutics Inc.:
Venous ulcer
Nexagon
CoDa

Study placed in the following topic categories:
Varicose Ulcer
Skin Diseases
Varicose Veins
Ulcer
Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009