In this study, the objective is to evaluate the effectiveness of a single application of
human Connective Tissue Allograft (CTA) as a treatment of LET. CTM Biomedical markets and
distributes decellularized particulate human placental connective-tissue matrix products,
intended solely for homologous use to supplement or replace damaged or inadequate
connective-tissue. These are structural tissue allografts processed according to the criteria
contained in 21CFR 1271.10(a) for regulation solely under section 361 of the Public Health
Service Act. Drug/Device Handling: If the research involves drugs or device, describe your
plans to store, handle, and administer those drugs or devices so that they will be used only
on subjects and be used only by authorized investigators.