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| |  ETRS/WHS MEETING: Apligraf More Effective Than Standard Care For Diabetic Foot Ulcers CANTON, MA -- Aug. 25, 1999 -- Organogenesis Inc. today announced that the results from the completed Apligraf(R) pivotal trial in diabetic foot ulcers show use of Apligraf heals significantly more ulcers and heals them significantly faster than standard care alone. Apligraf is the first living product -- and the only skin construct -- to show efficacy in diabetic foot ulcers in a prospective, randomised, controlled pivotal trial. The study results were presented today at a medical symposium being held in conjunction with the joint European Tissue Repair Society/ Wound Healing Society multinational meeting in Bordeaux, France. The Apligraf diabetic ulcer pivotal trial was conducted at 24 medical centres across the US. A total of 208 patients were treated with either Apligraf plus standard care or diabetic foot ulcer standard care alone. Patient baseline characteristics were comparable between treatment groups. Efficacy was assessed at 12 weeks. Patients were followed for six months. The results found that 56 percent of Apligraf-treated ulcers healed by 12 weeks, compared with 38 percent of ulcers receiving standard care alone. Average time to healing was 65 days for Apligraf-treated ulcers, compared with 90 days for ulcers receiving standard care alone. About 16 million people in the U.S., or six percent of the population, have diabetes. Approximately one in every seven diabetics will ultimately suffer from at least one diabetic foot ulcer. Currently, 600,000 to 800,000 people in the US have diabetic foot ulcers. Foot complications are the most frequent cause of hospitalisation among outpatient diabetics and diabetic foot ulcers often lead to amputation. Each year, 50,000 to 70,000 amputations are performed on diabetics in the U.S. A panel of diabetic medical experts recently estimated that about one in every five diabetic foot ulcers ultimately leads to amputation. In addition to the high personal toll, diabetic foot ulcers are conservatively estimated to cost the healthcare system over $1 billion US per year. "Despite the important medical advances that have been made in the treatment of diabetic foot ulcers in the past fifty years, there remains a significant need for more effective therapies," said Aristidis Veves MD, DSc, research director at the Foot Center at the Beth Israel Deaconess Medical Center (formerly The Joslin Clinic). "We were pleased to participate in this trial and were impressed with the results seen at our centre, which we have presented and published." Like human skin, Apligraf is living, all-natural and bi-layered, with both an upper epidermal and a lower dermal layer. It contains living human skin cells -- epidermal keratinocytes and dermal fibroblasts. The keratinocytes are differentiated to form the strata of the human epidermis, including the outer stratum corneum. Unlike human skin, Apligraf does not contain Langerhans cells, melanocytes, macrophages or lymphocytes, or structures such as blood vessels, hair follicles and sweat glands. Apligraf is the only manufactured product containing living human cells to have gained FDA PMA marketing approval: in May 1998, Apligraf was approved for use in the treatment of venous leg ulcers, another type of chronic wound. Additional potential uses for Apligraf include use in skin surgery, burns, skin disruptive diseases such as epidermolysis bullosa and other types of chronic wounds such as pressure sores.
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