A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on venous leg ulcers.

Inclusion Criteria:

• Be 18 years of age or older.
• Have evidence of venous insufficiency documented by venous duplex scanning or impedance plethysmography within the past 6 months. The study report must contain the actual terms "venous incompetence" or it must be repeated.
• Have a venous ulcer of >3 but <25 cm2 in area, by planimetry.
• Have a venous ulcer that has been open continuously for >1 but <18 months prior to treatment.
• Have been in the prescribed compression for at least 7 days immediately prior to randomization, but no more than 14 days (consecutive or non-consecutive).
• If female, the subject must: be postmenopausal without menses for at least 1 year, or have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or have a negative serum Human Chorionic Gonadotropin (HCG) and be willing to practice an approved form of birth control for the duration of the trial.
• Subject agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB-approved informed consent.

Exclusion Criteria:

• Have the designated study wound below the malleolus or above the popliteal fossa.
• Have been treated with becaplermin (PDGF-BB) or any other topical recombinant therapy to the study wound within the 30 days prior to randomization.
• Have had the study wound treated, at any time, with a skin substitute or an autologous growth factor.
• Have had a surgical procedure to treat venous or arterial disease of the affected limb within the past 90 days.
• Have evidence of significant arterial insufficiency (i.e. an ankle brachial index of < 0.8). Subjects with an ABI >1.0 must have a toe brachial index (TBI) of > 0.6 or a supine transcutaneous oxygen measurement on the affected leg and distal to the wound of >30mmHg.
• Have clinical evidence of active infection at the wound site.
• Have evidence of active vasculitis, cellulitis or collagen vascular disease.
• Have participated in a clinical trial of an investigational agent within the last 30 days.
• Have significant acute or chronic diseases (i.e., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or infectious diseases) that are not adequately controlled by medical treatment as determined by the Investigator's judgment.
• Have diabetes mellitus with a hemoglobin A1c > 10%.
• Have an active skin disease, such as psoriasis, which could impair the ability to assess the study wound.
• Have an allergy to the components of the dressings used in this study.
• Require concomitant use of pentoxifylline or clopidogrel bisulfate during the study.
• Have undergone enzymatic debridement of the study wound at any time during the 7 days prior to the first application of study treatment.
• Have any requirement for the use of systemic steroids or immunosuppressive or cytotoxic compounds during the period of the study or received low-dose steroid therapy for more than 5 days within the past year.
• Expect to undergo hyperbaric oxygen therapy at any time during the study.