a post-marketing clinical study of apligraf for venous leg ulcers

Conditions: Varicose Ulcer

Summary: single site clinical study utilizing the novel technology of microarrays to identify and characterize the molecular mechanisms through which apligraf promotes healing of venous leg ulcers.


Eligibility criteria:
inclusion criteria: * subject has non-infected partial or full-thickness venous leg ulcer for a duration of four weeks or greater which has not adequately responded to conventional therapy * stage ii or iii ulcer as defined by the iaet/wocn ulcer classification guide listed in appendix iv. * subject is female and 18 years of age or older. * subject with venous leg ulcer (target ulcer) between 5 - 40 cm2 in size. * sexually active females must be practicing a medically proven form of contraception during the course of the study period. * subject or legal guardian must have read, understood and signed an institutional review board (irb) approved informed consent form. * subject and/or legal guardian must be able and willing to follow study procedures and instructions. exclusion criteria: * subject whose target ulcer has healed 60% or greater in area from post debridement (if applicable) baseline screen (visit 1) to post debridement day 0 (visit 2) as determined by wound tracings. * subjects who are being treated with vac® (vacuum assisted closure™) therapy. * subject has arterial disease as determined by an ankle brachial index (abi ) of \<0.65. * subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hba1c \> 12%), cancer (biopsy confirmed active malignancy), positive hiv test, or any disorder(s) that may compromise wound healing. * subjects who are currently receiving, or have received at any time within one month prior to entry into the study, corticosteroids (\>15 mg/day), immunosuppressive agents, radiation therapy, hemodialysis or chemotherapy. anticipated use of the above agents will exclude subjects from entry into the study. * clinical vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases. * signs and symptoms of cellulitis or osteomyelitis. * necrotic or avascular ulcer beds. * venous leg ulcer with exposed bone, tendon or fascia. * subject with the presence of recent infections in the area intended for treatment. * known hypersensitivity to bovine collagen or to the components of the apligraf agarose shipping medium. * subject who is lactating or pregnant (hcg positive as determined by lab testing). * subject with liver (alt/sgpt, alp, ast/sgot, bilirubin, albumin, total protein, ldh) and/or renal function (bun and creatinine) tests greater than 2 x upper limit of normal (uln) or albumin \< 2.5 mg/dl. * subject enrolled in any wound or investigational device study for any disease within the past four weeks. * subject previously treated at target site with apligraf, dermagraft or any other cell therapy at the target site. * subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes. * subject who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol