New Study Shows Diabetic Foot Ulcers Treated with OASIS® Ultra Tri-Layer Matrix Demonstrated Significantly Better and More Rapid Wound Closure Compared to Standard Care

FORT WORTH, Texas, April 30, 2015 /PRNewswire/ -- Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, today announces that a new study published today in Advances in Wound Care has found that diabetic foot ulcers, a common and serious complication of diabetes, treated with OASIS Ultra Tri-Layer Matrix, an advanced wound management product, resulted in superior wound closure compared to standard of care treatments. The study demonstrated that weekly treatment with OASIS Ultra Tri-Layer Matrix over 12 weeks resulted in significantly more wound closures (54 percent versus 32 percent), greater reduction in wound size and achieved wound closure two weeks earlier than standard care.¹ This data is also being presented on Friday, May 1 at the 2015 Symposium on Advanced Wound Care (SAWC) Annual Meeting in San Antonio, TX.

The randomized, controlled and open-label multicenter study enrolled 82 patients with type 1 or type 2 diabetes and compared wound management over 12 weeks plus an additional four-week follow up with OASIS Ultra Tri-Layer Matrix to standard of care methods for wound care, as selected by the study investigator, including silver dressings, hydrogel, wet-to-dry wound dressings and triple antibiotic dressings. It is the first randomized, controlled and open-label study to evaluate OASIS Ultra Tri-Layer Matrix in the study population.

"Diabetic foot ulcers have a significant impact on a patient's quality of life and place patients at higher risk for lower limb amputations," said lead investigator Shawn M. Cazzell, DPM, Valley Vascular Surgery Associates, St. Agnes Medical Center in Fresno, CA. "In some cases, diabetic foot ulcers can be fatal if they fail to make healing progress and become infected. As such, it is critically important to identify effective treatments that promote rapid and complete wound closure. The results of the OASIS Ultra Tri-Layer Matrix study were quite powerful and underscore the need for a shift in the way doctors approach the management of foot ulcers in patients with diabetes."

Additional Study Details:

• The study's primary endpoint found a significantly greater proportion of ulcers closed at the end of the 12-week treatment period versus the control group (54 percent versus 32 percent, P=0.021).¹
• The study's secondary endpoints were time to ulcer closure and percent change in ulcer area from baseline. As early as one week following randomization, there was a significant difference in the percent reduction in ulcer area (size) for the wounds managed with OASIS Ultra Tri-Layer Matrix (all P values <0.05).¹ 
• Ulcer closure was defined as 100 percent re-epithelialization, no drainage and no need for a dressing.
• The study was conducted at 11 U.S. centers in California, Indiana, Louisiana, Texas and Virginia.
• The product was found to be safe; reported adverse events were not related to study treatment and were those common to the population being studied. Adverse events were evenly distributed in both treatment and control groups.¹

"The results of this study are extremely encouraging and provide well validated evidence for the clinical value of OASIS Ultra Tri-Layer Matrix in the management of diabetic foot ulcers, consistent with prior trials of OASIS Wound Matrix," said Bert Slade, MD, Chief Medical and Scientific Officer, Smith & Nephew Advanced Wound Management.

About Diabetic Foot Ulcers
Diabetes is among the most common chronic medical conditions, affecting 29.1 million people in the United States.² Up to 25 percent of people with diabetes are at lifetime risk for diabetic foot ulcers, which are an enormous disease burden.³ They are frequently difficult to treat, costly, and can impact an individual's quality of life, physical functioning and productivity.² Diabetic foot ulcers often fail to heal due to poor blood glucose control, necrotic tissue, infection, chronic inflammation and inadequate perfusion. They are a leading cause of lower limb amputations and the most common reason for hospital admissions among people with diabetes.³

About OASIS Ultra Tri-Layer Matrix
The three-dimensional architecture of OASIS Ultra Tri-Layer Matrix is cleared to effectively manage wounds. The OASIS product's naturally derived biomaterial—collagen, proteoglycans and glycoproteins—closely mimics normal skin ECM function, replacing key structural components that are missing or failing in wounds. In many patients, replacing these components can help restart the body's own healing process.

OASIS Ultra Tri-Layer Matrix is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).

OASIS Ultra Tri-Layer Matrix is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. This product is not indicated for use in third-degree burns.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals in their daily efforts to improve the lives of their patients. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 100 countries. Annual sales in 2014 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.

^® OASIS Ultra Tri-Layer Matrix is a registered trademark of Cook Biotech. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com