Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that it has initiated a pivotal trial of Dermagraft® in subjects with venous leg ulcers (DEVO-Trial) to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers (VLUs). Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA-approved for the treatment of diabetic foot ulcers (DFUs) and used in over 1,000 wound care and outpatient clinics in the U.S.
“We are very eager to begin evaluating the efficacy of Dermagraft in the treatment of VLUs,” said Jan Lessem, M.D., Ph.D., Vice President and Chief Medical Officer of ABH. “Dermagraft has been applied over 150,000 times to speed the healing process in DFUs. The success of this pivotal trial will mean adding an additional indication for Dermagraft and furthering our customers’ ability to use regenerative medicine to help heal their patients.”
The international pivotal trial will enroll more than 400 patients in eight countries, making it the largest randomized, controlled clinical study on a skin graft and/or bioengineered skin replacement planned to date. It is designed as a prospective, multicenter, randomized, controlled clinical study, in which subjects are assigned into one of two groups. The experimental group receives weekly applications of Dermagraft and four-layer compression dressings while the active comparator group receives weekly applications of four-layer compression dressings only.
The Company has initiated patient enrollment and activated 30 clinical centers globally. ABH expects to complete the study in May 2011. Principal investigators for the study are:
- William Marston, MD, Associate Professor of Surgery, Division of Vascular Surgery at the University of North Carolina at Chapel Hill
- Keith Harding, MD, Professor, Department of Wound Healing at the Cardiff University School of Medicine in Wales, UK
- David Bergqvist, MD, Ph.D., Department of Surgery at the Uppsala University Hospital in Sweden
“I am excited to be involved in testing the efficacy and safety of Dermagraft to improve the healing of venous leg ulcers,” said lead U.S. investigator, William Marston, MD, Professor of Surgery and Chief of the Division of Vascular Surgery at the University of North Carolina at Chapel Hill. “As a vascular surgeon, I see a significant number of lower extremity chronic wounds that either do not heal or heal too slowly, often leading to increased risk of amputation, increased patient morbidity and greater cost to the patient and health care system. Based on the proven clinical efficacy of Dermagraft in improving the healing of chronic DFUs, Dermagraft may be well suited for additional indications, including treatment of VLUs.”
Advanced BioHealing, Inc.