Insurance providers spend millions of dollars on prosthetics and pressure reducing modalities for diabetes-related wound care; however, no scientific data exists on shear (friction) and scarce data on pressure reduction. Presently, no commercially available removable cast walker reduces shear. Salix Medical's (patent pending) removable cast walker (ACE walker) uses a unique shear modulation technology to eliminate peaks in pressure and shear at the sole of the foot. Such peaks usually initiate or exacerbate a destructive pathway that involves ulceration and may well lead to amputation in patients with diabetes. This randomized clinical trial will evaluate the 1) ACE walker versus 2) the clinical 'gold standard"""""""" Total Contact Casts and 3) standard Healing Sandals to heal diabetic foot ulcers. In addition the study will evaluate functional status and health care costs among treatment groups. Three groups of thirty-five diabetics with neuropathic ulcerations will be selected to participate in a 12-week clinical trial. At baseline, and at two week intervals, clinical evaluations will be performed to assess wound size and depth.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK056571-02
Application #
6550685
Study Section
Special Emphasis Panel (ZRG1-SSS-5 (10))
Program Officer
Jones, Teresa L Z
Project Start
1999-09-30
Project End
2004-07-31
Budget Start
2002-09-30
Budget End
2003-07-31
Support Year
2
Fiscal Year
2002
Total Cost
$424,253
Indirect Cost
Name
Diabetica Solutions, Inc.
Department
Type
DUNS #
115243805
City
San Antonio
State
TX
Country
United States
Zip Code
78249