KCI Announces Positive Results From Clinical Study Utilizing V.A.C.(R) Therapy in the Treatment of Diabetic Foot Ulcers
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- Published on Wednesday, 02 May 2007 04:00
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SAN ANTONIO,TX, USA | May 1, 2007 | Kinetic Concepts, Inc. (NYSE:KCI), a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces, today announced the acute phase results of a randomized, controlled, clinical trial (RCT) on the use of KCI’s V.A.C.® Therapy in the treatment of complex diabetic foot ulcers where the use of V.A.C. Therapy resulted in the following benefits:
- a significant increase in the number of wounds that completely closed
- a significant improvement in the time to achieve wound closure, and
- a significant improvement in the formation of granulation tissue, which is essential for successful wound healing.
Further, the superior efficacy of V.A.C. Therapy led to a significant reduction in the incidence of amputation for patients with these complex wounds. This is the first time that a wound healing modality has been shown to have an impact on limb salvage.
This trial is the first large, multi-center RCT utilizing V.A.C. Therapy in the treatment of this wound type. It involved 335 investigational subjects with complex, hard-to-heal diabetic foot ulcers across 37 participating centers in the U.S. Wounds treated with V.A.C. Therapy demonstrated a statistically significant improvement over control therapy in achieving total closure, the study’s primary endpoint (43.2% vs. 29.5%, p=0.009). In addition, wounds treated with V.A.C. Therapy, achieved closure in significantly fewer days (p=0.009), developed significantly more granulation tissue (p=0.008), and resulted in significantly fewer amputations (7 vs. 17, p=0.03) when compared to control. Investigators presented results of the study to attendees at the annual Symposium on Advanced Wound Care conference in Tampa, FL., the largest gathering of multi-disciplinary wound care clinicians in the U.S.
The study findings are important because an estimated fifteen percent of all diabetics will eventually experience a significant wound resulting in amputation. “This study further substantiates the growing body of evidence that KCI’s V.A.C. Therapy is uniquely effective in treating even the most challenging wound types,” said Dr. Todd Fruchterman, Chief Technology Officer of KCI. “This research represents an important step in establishing V.A.C. Therapy as the standard of care for diabetic foot wounds, and KCI will continue to invest in pioneering research that will further improve patient care and outcomes in this, and other clinical settings.”
Kinetic Concepts, Inc. is a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces. We design, manufacture, market and service a wide range of proprietary products that can improve clinical outcomes while helping to reduce the overall cost of patient care. Our advanced wound care systems incorporate our proprietary V.A.C. brand technology, which has been clinically demonstrated to help promote wound healing and can help reduce the cost of treating patients with serious wounds. Our therapeutic surfaces, including specialty hospital beds, mattress replacement systems and overlays, are designed to address pulmonary complications associated with immobility and to prevent skin breakdown. We have an infrastructure designed to meet the specific needs of medical professionals and patients across all health care settings including acute care hospitals, extended care facilities and patients' homes both in the United States and abroad.
This press release contains forward-looking statements, including statements regarding the clinical evidence relating to and future clinical studies of V.A.C. Therapy, and the establishment of V.A.C. Therapy as the standard of care. These forward-looking statements are based on our current expectations and are subject to a number of uncertainties. All information set forth in this release is as of its date, and we undertake no duty to update this information. More information about the company is described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2006 on file with the SEC and available at the SEC’s website at www.sec.gov.
SOURCE: Kinetic Concepts, Inc.