Tag: Chronic venous leg ulcers

Osiris Announces Enrollment of Patients in a Clinical Trial Evaluating

     GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers

 

COLUMBIA, Md., July 11, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (OTC Pink:OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced the initiation of its “Multicenter, Prospective, Randomized, Open-Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPL PRIME™ in the Treatment of Chronic Venous Leg Ulcers.”

 

This study is expected to enroll up to 200 patients in approximately 30 clinical sites. Patients will be randomized 1:1 to receive GrafixPL PRIME plus standard compression therapy (SOC) versus SOC alone in patients with chronic venous leg ulcers (VLUs). The study objective is to evaluate the safety and efficacy of weekly applications of GrafixPL PRIME plus SOC versus SOC alone for chronic VLUs with a size between 1 cm2 and 25 cm2. Patients in the SOC alone group whose ulcers do not close will be offered GrafixPL PRIME adjunct to SOC in a crossover extension treatment phase of up to 12 treatments … read more

Managing chronic venous leg ulcers

what’s the latest evidence?

 

Chronic venous leg ulcers (CVLUs) affect nearly 2.2 million Americans annually, including an estimated 3.6% of people over the age of 65. Given that CVLU risk increases with age, the global incidence is predicted to escalate dramatically because of the growing population of older adults. Annual CVLU treatment-related costs to the U.S. healthcare system alone are upwards of $3.5 billion, which are directly related to long healing times and recurrence rates of over 50%.

 

CVLUs are not only challenging and costly to treat, but the associated morbidity significantly reduces quality of life. That makes it critical for clinicians to choose evidence-based treatment strategies to achieve maximum healing outcomes and minimize recurrence rates of these common debilitating conditions. These strategies, which include compression therapy, specialized dressings, topical and oral medications, and surgery, are used to reduce edema, facilitate healing, and avert recurrence read more