MacroCure Names AAWC Official Lead Clinical Trial Investigator
Vickie R. Driver, DPM, MS, FACFAS, has been nominated as the lead principal investigator of a Phase III clinical study on chronic lower-extremity ulcers currently being conducted in the US, Canada, and Israel by MacroCure, an international biotechnology company.
The trial reportedly includes 400 adult patients who live with chronic ulcers of the lower extremities that are being treated with CureXcell.® The objective of the study is to evaluate the safety and efficacy of CureXcell as an adjunct to wound care, according to MacroCure officials. The trial is being conducted as a randomized, double-blind, parallel group, sham-controlled study.
Driver, president-elect of the American Association of Advanced Wound Care (AAWC), also currently serves as chief of podiatric surgery/director of research for limb preservation and wound healing with the VA New England Health Care Division’s department of surgery. Additionally, she is active with the Wound Healing Center of Rhode Island Hospital, a Brown University teaching hospital, and has served as director of clinical research, limb preservation and wound care, and international research fellowship programs at Boston Medical Center. She was also an associate professor of surgery at Boston University School of Medicine.
“I am pleased to have been appointed as principal investigator for MacroCure’s Phase III clinical study,” Driver said. “Previous studies of MacroCure’s innovative CureXcell cell therapy treatment have demonstrated positive results, indicating the tremendous potential it holds for the treatment of hard-to-heal wounds currently effecting millions of people suffering from diabetes mellitus, hypertension, coronary artery disease and other chronic conditions.”
“We are excited to have someone with Dr. Driver’s credentials and experience in wound healing leading this next phase of trials exploring CureXcell’s potential for treating patients with hard-to-heal wounds,” said Nissim Mashiach, president and CEO of Macrocure. “The multinational trial currently underway follows our successful treatment of ulcer patients in Israel and will allow us to advance our solution in the global market.”
California Wound Center Appoints Medical Director
Board-certified vascular surgeon Omar Araim, MD, has been named medical director for the Adventist Health Wound Healing Center in Hanford, CA. Araim earned his medical degree at Emory University School of Medicine, followed by general surgery training at Medical College of Virginia Hospitals and vascular surgery training at Yale University’s Vascular Surgery Division and Ann Arbor’s St. Joseph Mercy Hospital. He completed his fellowship training at Cleveland Clinic.
The center features a team of board-certified physicians that provides a multidisciplinary approach to chronic wound issues. Physician specialties include general surgery, podiatry, and vascular surgery. The center is also staffed with experienced wound care nurses.
Few Docs Meeting Meaningful Use, Study Shows
While more physicians overall are said to be utilizing electronic health records (EHRs), only a small sampling of them have met Stage I of Meaningful Use, according to a new study.
A national survey released in March 2012 showed that 43.5% of physicians reported having a basic EHR (up from 34% in 2011), but only 9.8% said they met criteria for Meaningful Use, according to Mathematica Policy Research, Cambridge, MA. The results followed a 2012 survey from the National Center for Health Statistics that only reported about 25% of physicians had computers in their respective practices that were equipped to meet Stage I Meaningful Use, which earns eligible providers up to $44,000 in extra payments from Medicare and Medicaid. Eligible professionals who don’t meet the requirements are subject to penalties beginning in 2015.
The Mathematica study also concludes 9.8% of physicians met the criteria (11.2% among primary care physicians and 7.6% among specialists). Among primary care physicians, 40.5% had 8-10 Meaningful Use functions, as did 36.5% of specialists. Among primary care physicians and specialists, 14.6% and 12%, respectively, had 0 functions.
According to researchers, more than half of respondents reported they were not planning to participate in the Meaningful Use incentive program (17.7%) or didn’t know if they would participate (36.1%). However, 25% had registered for payments.
Researchers received 1,820 responses (60% response rate) to a questionnaire on basic EHR adoption and ability to meet criteria sent to physicians in the American Medical Association’s Physician Masterfile. Among the respondents, 62% were primary care physicians and 56% were specialists. The study authors’ measure of Meaningful Use reportedly included 11 of 15 core requirements for Stage I.