Osiris says all wounds reached complete closure in Grafix effectiveness review
Osiris Therapeutics announced that a new peer-reviewed manuscript by physician and surgeon Jonathan Smedley, DPM, FACFAS, entitled "Wound Closure in Smoking Peripheral Arterial Disease Patients with Treatment Refractory Ulcerations: A 12-month Follow-up Case Series," has been published in the International Journal of Lower Extremity Wounds and is available on-line. A 1-year, single-center effectiveness review was conducted on the clinical outcomes in actively smoking peripheral arterial disease patients treated with Grafix(R) for use in the treatment of refractory lower extremity ulcerations. Wound types included chronic ischemic and neuroischemic ulcerations and wounds of mixed venous and arterial etiology. Wounds were characterized by an average size of 4.6 cm2 and a previous duration of 53 weeks with a failure to respond to standard of care and other advanced treatment measures. 80% of the patients were diabetic. Daily cigarette consumption for the patients ranged from 1/2 pack to greater than 1 pack per day, and the mean ankle brachial index for the group was 0.7. More than half of the patients were not candidates for revascularization procedures. Study Outcomes: all wounds reached complete closure and remained closed at the 12-month follow up; the mean time to closure was 7.8 weeks with a mean graft use of 7.0 grafts; the mean 4-week percentage of wound area reduction was 69.4%; there were no adverse events attributed to the use of Grafix. "Patients often times present with a variety of comorbid conditions that pose challenges to wound care providers. Some refractory wounds persist despite long term multidisciplinary efforts to promote timely closure. Options such as Grafix allow us to pursue management of these lower extremity ulcerations to the point of resolution. This is extremely valuable, especially in the high-risk diabetic population," said Dr. Smedley.