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

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