Status:
COMPLETED
A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)
Lead Sponsor:
OcuNexus Therapeutics, Inc.
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 af...
Eligibility Criteria
Inclusion
- Diagnosis of venous leg ulceration
- Ankle brachial index of \> 0.80 measured during screening or within three months prior to the Day -14 visit.
- Reference ulcer area greater than 1 cm2 and less than 25 cm2
- Reference ulcer present for at least 4 weeks
- Have an ankle circumference of greater than 18 cm
- Male of female patients aged 18 years or over
- Able to tolerate effective compression bandaging
- Patients able to walk independently with or without mobility aids
- Able and willing to give informed consent
- Able and willing to attend all follow up visits
Exclusion
- Significant change in ulcer size in the screening period screening period
- Presence of a non-study ulcer within 2.0 cm of the reference ulcer
- Wound bed with exposed bone, tendon or fascia
- Patients with leg ulceration etiology other than venous insufficiency
- Patients who require wheel chairs for normal mobility
- Patients who have any ulcer (reference or non-reference) which shows signs of clinical infection
- Patients who have any ulcer (reference or non-reference) positive for β-hemolytic streptococcus upon culture.
- Patients who are unable to tolerate or comply with the standardized compression bandaging protocol specified in this protocol
- Female patients who are pregnant or breastfeeding.
- Patients who are currently taking:
- Pentoxifylline (Trental®)
- Immunosuppressive therapy
- Oral corticosteroid therapy or topical corticosteroid on the leg where the reference ulcer is located
- Growth factors (e.g. Regranex)
- Cell cultures or topical skin factors
- Patients with:
- Renal insufficiency defined as an estimated GFR which is \< 30 mL/min/1.7m2
- Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range
- Hepatic insufficiency defined as total bilirubin \> 2 mg/dL or serum albumin \< 25 g/L
- HbA1c \> 8.5%
- Hemoglobin \< 10 g/dL
- Hematocrit \< 0.30
- Platelet count \< 100,000
- Patients have had a myocardial infarction within the previous 6 months or patients with unstable angina pectoris
- Patients with:
- Collagen vascular disease
- Severe rheumatoid arthritis
- Cellulitis or osteomyelitis
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00820196
Start Date
March 1 2009
End Date
May 1 2010
Last Update
September 18 2012
Active Locations (10)
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1
Centre for Clinical Research
San Francisco, California, United States, 94546
2
Pacific Wound Center
Stockton, California, United States, 95204
3
Penn North Centers for Advanced Wound Care
Erie, Pennsylvania, United States, 16544
4
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201