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

Completed · Phase 2

Conditions studied: Venous Ulcer

In brief

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.

Key facts

Study ID

NCT00820196

Run by

OcuNexus Therapeutics, Inc.

People needed

98

Starts

2009-03-01

Expected to finish

2010-05-01

Last updated by the study team

2012-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Centre for Clinical Research — San Francisco, California, United States
• Pacific Wound Center — Stockton, California, United States
• Penn North Centers for Advanced Wound Care — Erie, Pennsylvania, United States
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States
• Waitemata District Health Board — Auckland, Auckland, New Zealand
• District Nursing and Leg Ulcer Service A+Links Home Health — Auckland, New Zealand
• Home Health Services Papakura — Auckland, New Zealand
• Nurse Maude — Christchurch, New Zealand
• Dunedin Hosptial — Dunedin, New Zealand
• Waikato Hospital — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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