Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy.
Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.
|Venous Leg Ulcer Venous Stasis Ulcer||Device: Bilayered Cellular Matrix (OrCel)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270946
|United States, Alabama|
|Terry Treadwell, MD|
|Montgomery, Alabama, United States, 33134|