A Post-Marketing Clinical Study of Apligraf for Venous Leg Ulcers

This is an interventional treatment trial for Varicose Ulcer Read More

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