Healthcare Industry News: Diabetic Foot Ulcer
News Release - February 11, 2008
Final Study Results Show V.A.C.(R) Therapy to be More Efficacious Than Advanced Moist Wound Therapy in Treating Diabetic Foot UlcersResults to be Published in ADA Journal "Diabetes Care"
SAN ANTONIO--(HSMN NewsFeed)--Kinetic Concepts, Inc. (NYSE:KCI ) today announced the final efficacy results of a randomized controlled clinical trial (RCT) on the clinical efficacy of KCI’s V.A.C.® System negative pressure wound therapy (NPWT) compared to advanced moist wound therapy (AMWT) to treat diabetic patients with foot ulcers. The study, which showed that V.A.C. Therapy is more efficacious than AMWT in the treatment of Diabetic Foot Ulcers, will be published in the April 2008 issue of Diabetes Care, the peer-reviewed journal of the American Diabetes Association. A pre-print version of the article is currently available online at http://diabetes.org/diabetescare.
Highlights of the multi-center, RCT trial include:
- A greater proportion of foot ulcers achieved complete ulcer closure with V.A.C. Therapy versus AMWT;
- Time to wound closure was less with V.A.C. Therapy than with AMWT;
- Patients on V.A.C. Therapy experienced significantly fewer amputations.
The study is the largest RCT to date comparing V.A.C. Therapy with AMWT in the treatment of this wound type. It involved 342 patients with complex, hard-to-heal Diabetic Foot Ulcers with 90% of therapy days occurring in the home care setting. In the study, for patients on V.A.C. Therapy, complete ulcer closure was significantly greater than for those patients on AMWT (43.2% vs. 28.9%, p=0.007). Patients treated with V.A.C. Therapy healed significantly (p=0.001) faster (Kaplan-Meier median estimate time to 100% ulcer closure = 96 days) compared to AMWT (time to 100% ulcer closure not determinable). In addition, significantly fewer amputations were observed in V.A.C. Therapy patients compared to AMWT (4.1% vs. 10.2%, p=0.035). In assessing safety, the study showed that no significant difference between the groups was observed.
“This study further confirms results of a similar study of amputated diabetic foot wounds published in The Lancet on November 12, 2005,” said Dr. Dan Ciaburri, KCI’s Chief Medical Officer. “It also adds to KCI’s significant body of clinical data that clearly shows that our V.A.C. Therapy system, including its unique foam dressing, provides clinical advantage for treatment of Diabetic Foot Ulcers.”
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 and can help reduce the overall cost of patient care. Our advanced wound-care systems incorporate our proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy technology, which has been demonstrated clinically to promote wound healing through unique mechanisms of action 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, to reduce skin breakdown and assist caregivers in the safe and dignified handling of obese patients. 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 organizations and patients’ homes, both in the United States and abroad. For more information, visit www.kci1.com.
This press release contains forward-looking statements. 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, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2007, both of which are on file with the SEC and available at the SEC’s Web site at www.sec.gov.
Source: Kinetic Concepts
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