Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Amnioband Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment
Brief Summary:
Lower extremity ulcers pose significant clinical, humanistic and economic burdens on society. Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs).1-5 Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Human amniotic membrane replaces the damaged extracellular matrix characteristic of chronic ulcers. In addition, it contains cytokines that may accelerate healing. In clinical practice and recent studies, Dehydrated Human Amniotic Membrane has appeared to be as effective as bioengineered skin products. This RCT is designed to evaluate Amnioband Dehydrated Human Amniotic Membrane in venous leg ulcers.