Amnioband and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers

This study is a multi-center, randomized, trial designed to evaluate the safety and effectiveness of Amnioband Dehydrated Human Amniotic Membrane plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The choice of compression will be at the discretion of the principle investigator. The Screening Phase (1-14 days) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), At or up to 14 days before the first Screening Period Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure. Subjects who have not been treated with compression therapy for the target ulcer must receive a minimum of 14 days of compression prior to enrollment. At the first Screening Period Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer. The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Period of the study. The Treatment Phase (12 Weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Subjects who continue to meet eligibility criteria will be randomized to one of three groups: (1) standard of care: multi-layer compression (2) weekly application of Amnioband Dehydrated Human Amniotic Membrane (3) biweekly applications of Amnioband Dehydrated Human Amniotic Membrane. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using a digital camera device. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subjects in any of the three groups whose ulcers do not achieve closure at 12 weeks will be deemed treatment failures. Subjects in the control arm may cross over to the Amnioband arm if they fail to achieve closure although these subjects will not be included in the analysis.