ULURU Inc. Announces Additional Data Supporting Altrazeal(R) Use in Diabetic Foot Ulcers
- Offers Potential for Significant Savings and Improved Healing Relative to Best Current Clinical Practice -
ADDISON, Texas, Oct. 27, 2011 /PRNewswire/ -- ULURU Inc. (NYSE AMEX: ULU), today announced that additional data supporting the use of Altrazeal® in the treatment of Wagner Grade 2 diabetic foot ulcers was presented at a recent medical conference.
Currently, the best clinical practice used in the treatment of diabetic foot ulcers is to use a contact cast, which takes the pressure off the ulcer and ensures patient compliance, as the contact cast cannot be removed by the patient. Extensive medical literature (including Armstrong, D.G.; Lavery, L.A.; Wu, S.; Boulton, A. J. Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wound: A Randomized Controlled Trial. Diabetes Care 2005; 28: 551-554) demonstrates that by using contact cast offloading, considered the "Gold Standard" in treating diabetic Wagner Grade 2 neuropathic foot ulcers, healing time is approximately 42 days. Contact casts are only used in the treatment of approximately 10 – 15% of Wagner Grade 2 diabetic neuropathic foot ulcers in part due to the inconvenience to the patient and perceived application difficulties. However, extensive research has demonstrated that use of a removable off-loading device also provides clinical advantages.
Consequently, removable off-loading devices are more commonly used. The disadvantage of this off-loading treatment is patient compliance, due to failure of the patient to consistently wear the off-loading device. In the reported case series conducted by Dr. Jeffery Ross, DPM, FAPWCA, Clinical Associate Professor, Baylor College of Medicine and Chief of the Diabetic Foot Clinic, Quentin Meese County Hospital, Houston, Texas; Altrazeal® used in combination with a removable off-loading device was studied in 10 patients. The range in time to heal was 28 - 35 days, which is an improvement of 7 - 14 days compared with using contact casting.
Commenting on the case series, Dr. Ross, stated, "The results I have seen in using Altrazeal® in the case series and with other patients have been positive. The porous architecture of the film created once the powder has aggregated provides optimal oxygen and vapour transpiration, tensile strength and flexibility protecting the wound during healing. The results show the potential for Altrazeal® to change clinical practice and become one of the standards of care for the treatment of neuropathic diabetic foot ulcers."
Relative to the cost associated with the use of a contact cast, using Altrazeal® in combination with a reusable removable off-loading device, could generate significant savings for the health care system as this is a less expensive treatment option exclusive of any cost benefit associated with an improvement in the time to heal the wound. In addition, this treatment offers improved patient convenience and comfort as the off-loading device can be removed when it is not required.
Commenting on the clinical data, Kerry P. Gray, President and CEO of ULURU, stated, "This is important data supporting the use of Altrazeal® in the treatment of diabetic foot ulcers. We now have positive clinical data using Altrazeal® with both a contact cast and a removable off-loading device which covers all standard of care treatment modalities for the treatment of diabetic foot ulcers. The cost to treat diabetic foot ulcers and the associated complications, including amputation, due to the failure to heal is an enormous burden for the health care system. The use of Altrazeal® in combination with both off-loading methods has shown the potential for significant cost savings, and improved clinical outcomes."
About ULURU Inc.:
ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex® Aggregate technology and OraDisc™ transmucosal delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com. For further information about Altrazeal®, please visit www.Altrazeal.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended. These statements are subject to numerous risks and uncertainties, including but not limited to our belief that contact cast off-loading is considered the best clinical practice and is the "Gold Standard" in treating diabetic Wagner Grade 2 neuropathic foot ulcers, that healthcare cost savings and improved clinical outcomes can be achieved by using Altrazeal in combination with off-loading devices, Altrazeal ® 's potential to change clinical practice and become one of the standards of care for the treatment of neuropathic diabetic foot ulcers, and the clinical and economic advantages of Altrazeal ® and to the risk factors detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and other reports filed by us with the Securities and Exchange Commission.
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
SOURCE ULURU Inc.
Web Site: http://www.uluruinc.com
Posted: October 2011