Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin).

Chronic venous leg ulcers are responsible for significant morbidity and health care costs worldwide. This pilot study evaluated the effectiveness 2 biologically active grafts, TheraSkin and Apligraf, in conjunction with compression therapy. The study, not industry-sponsored, was designed and conducted as a prospective, head-to-head, single-site, randomized clinical trial to assess differences in healing rates, adverse outcomes, and treatment costs. The healing rates were different but not statistically significant, there were no adverse outcomes, and TheraSkin averaged $2495.33 and Apligraf averaged $4316.67 per subject. This suggests that TheraSkin may provide equivalent or superior outcomes to Apligraf while reducing costs.

RCT Entities:   Population Interventions Outcomes