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

Launched by OCUNEXUS THERAPEUTICS, INC. · Jan 9, 2009

Keywords

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Gender

ALL

Eligibility 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