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A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)

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: NCT00820196
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
OcuNexus Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Venous Ulcer Drug: Nexagon® Drug: Nexagon® vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Complete healing of the treated Venous Leg Ulcer
  2. Reference ulcer wound healing as assessed by digital photographic planimetry
  3. Adverse Events


Information from the National Library of Medicine

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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
  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

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): NCT00820196


Locations
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United States, California
Centre for Clinical Research
San Francisco, California, United States, 94546
Pacific Wound Center
Stockton, California, United States, 95204
United States, Pennsylvania
Penn North Centers for Advanced Wound Care
Erie, Pennsylvania, United States, 16544
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
New Zealand
District Nursing and Leg Ulcer Service A+Links Home Health
Auckland, New Zealand
Home Health Services Papakura
Auckland, New Zealand
Waitemata District Health Board
Auckland, New Zealand
Nurse Maude
Christchurch, New Zealand
Dunedin Hosptial
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
OcuNexus Therapeutics, Inc.
Investigators
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Study Director: Scott Bannan OcuNexus Therapeutics, Inc.
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Responsible Party: OcuNexus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00820196    
Other Study ID Numbers: NEX-ULC-001
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012
Keywords provided by OcuNexus Therapeutics, Inc.:
Venous ulcer
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