a study to evaluate the clinical effectiveness of a collagen-orc antimicrobial matrix in venous leg ulcers

Conditions: Leg Ulcer

Summary: 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.


Eligibility criteria:
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 \ 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.