A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®

Inclusion Criteria: * Subject is a minimum of 18 years of age. * Subject has read, understood, and signed an Institutional Review Board (IRB)-approved Informed Consent Form (ICF). * Subject is able and willing to follow study procedures and instructions. * Subject reports moderate VLU-related pain (defined as ≥4 based on maximum pain level over preceding 24 hours) on numeric rating scale (NRS) at both Week -2 and Day 0). * Subject has a partial or full-thickness VLU between 1-60 cm2 and 1-36 months duration, which, in the opinion of the Investigator, has not adequately responded to conventional ulcer therapy. * Female subject of childbearing potential has a documented negative urine pregnancy test. * Subject (male or female) agrees to use highly effective methods of contraception for the duration of the study. Exclusion Criteria: * Subject has more than 1 VLU. * Female subject who is lactating. * Subject with significant or severe non VLU-related chronic pain which, in the Investigator's opinion, would impact subject's ability to evaluate their VLU-related pain. Subject with non-VLU-related chronic pain must be on a stable pain medication regimen and must, in the Investigator's opinion, not be anticipated to require a new pain medication for the chronic pain condition during the course of the study. * Subject is not willing to discontinue the use of topical analgesics at the VLU (topical anesthetic is permitted for debridement). * Subject who has arterial disease, as determined by an ankle-brachial index (ABI), of \<0.65. * Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to study enrollment. * Subject who is scheduled to have a vascular intervention on the study extremity during the study. * Subject with a biopsy confirmed active malignancy at the VLU. Also, subject with any active malignancy not at the VLU, with the exception of squamous cell carcinoma or basal cell carcinoma. * Subject who is currently receiving, anticipates receiving, or has received, at any time within 30 days prior to Screening visit, topical corticosteroids at the VLU. * Subject has vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases. * Subject has signs and symptoms of wound infection, cellulitis, or osteomyelitis at the VLU. * Subject has a VLU with an avascular wound bed. * Subject has a VLU with exposed bone, tendon, or fascia. * Subject has other wounds (DFU, surgical, etc.) on the same limb as the VLU. * Subject has a known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium. * Subject previously treated with Apligraf, or any other cell or tissue-based product at the VLU within 30 days of the Screening visit. * Subject who, in the opinion of the Investigator, has a history of alcohol or substance abuse within the previous year that could interfere with study compliance (eg, inability to attend scheduled study visits). * 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.