Diabetic Foot Health Restored by Topical Nitric Oxide Technology

Wellesely, MA

Monday, June 02, 2003

Diabetic Foot Health Restored by Nitric Oxide Technology

A study reported today at the 4th International Symposium on The Diabetic Foot at Noordwijkerhout, The Netherlands shows that the use of a new foot cream containing a patented transdermal L-Arginine preparation improves the health of the feet of diabetics suffering from the reduction of circulation. Diabetics, even those whose glucose levels are controlled, commonly suffer from vascular impairment. This is often manifest in the feet. The feet become cold and painful. In severe cases ulcers appear and, if allowed to progress, amputation can result.

In the study presented today at the Symposium on the Diabetic Foot Drs. Eric T. Fossel and Steven A. Shaya report that use of the transdermal L-Arginine cream significantly improved both temperature and blood flow in the feet of the diabetic subjects they studies. Temperature increased 5 degrees F at the metatarsal and 8 degrees F at the big toe. Flow increased 33% at the metatarsal and 35% at the achilles.

L-Arginine is a naturally occurring amino acid and is a classified as a dietary supplement. L-Arginine is the substrate of nitric oxide synthase, the enzyme which produces nitric oxide. Nitric oxide controls local blood flow by activating the production of cyclic-GMP. Cyclic-GMP in turn, causes the relaxation of the small blood vessel walls allowing blood to flow at its natural levels. Nitric oxide was the subject of the 1998 Nobel Prize in Medicine and once was named the "Molecule Of The Year" by Science magazine. Despite the intense interest in nitric oxide, practical applications have been slow in coming. The report today from the Netherlands is the first practical application of nitric oxide technology for human health.

The technology represented in today's report is licensed to Strategic Science & Technologies, Inc. of Wellesley MA. The company offers a variety of products based on that technology and is today introducing a product based on the above report for the feet of diabetics. The product has been named HealthiBetic Foot Cream. Details about this report and about HealthBetic Foot Cream can be obtained from Catherine Maker at 781 416 3777 or at info@strategicsciencetech.com

An abstract of the Netherlands report follows:

EVALUATION OF A TRANSDERMAL L-ARGININE PREPARATION ON THE CIRCUALTION IN THE DIABETIC FOOT: A PILOT STUDY

Eric T. Fossel, Ph.D.* and Steven A. Shaya, Ph.D.**

*Strategic Science & Technologies, Inc, Wellesley, MA. **Johnson & Johnson, Corporate Office of Science and Technology, New Brunswick, NJ

The aim of this study was to evaluate a transdermal cream containing the nitric oxide precursor, L-Arginine on the circulation in feet of diabetics. The cream contains L-Arginine in a hostile biophysical environment facilitating transfer of the L-Arginine from vehicle to tissue. Thirteen subjects completed the study which was designed as double blind with crossover with one week periods for wash out. Measurements were made of temperature of the big toe and metatarsal and flow measurements were made at the achilles and metatarsal. On post study analysis it was found that both temperature and flow were elevated at the end of the first one week wash out period. Though the study was completed according to protocol, the effect of L-Arginine did not wash out and the analysis of data needed to be recast. During the protocol each subject rubbed active on one foot and placebo on the other at the initial visit and then either active or placebo into their feet twice daily for a two week period. Values of temperature and flow were elevated in all groups at all visits. Comparing final and initial visits the following data was obtained. Flow: at metatarsal 11.6 +/- 5.5 vs 8.7 +/-4.3 (p<0.0001.); at achilles 11.4 +/-5.5 vs 8.4 +/- 2.5 (p=0.02). Temperature: metatarsal 86.9 +/-2.4 vs 82.0 +/-2.3 (p<0.0001); big toe 82.4 +/- 4.8 vs 74.4 +/- 4.2 (p<0.0001). We conclude that the application of topical L-Arginine in a transdermal cream improved both flow and temperature in the feet of the diabetic subjects studied and, to our surprise, the effect was long lasting.

Catherine Maker

Press Relations Officer

Strategic Science and Technologies, Inc.

Wellesley, MA

781-416-3777

781-516-3516

First Url: Strategic Science and Technologies, Inc.