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Abstract

Grant Number:	5R44DK056571-03
PI Name:	HIGGINS, KEVIN R.
PI Email:	higgins@xilas.com
PI Title:
Project Title:	Cast walker to Expedite Healing of Diabetic Foot Ulcer

Abstract: DESCRIPTION (provided by applicant): 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.

Thesaurus Terms:
assistive device /technology, biomedical equipment development, decubitus ulcer, diabetes mellitus, evaluation /testing, foot, medical complication, orthotics
biomechanics, diabetic neuropathy, gait, mechanical stress, orthopedics, wound healing
clinical research, human subject, patient oriented research

Institution:	XILAS MEDICAL, INC.
	12665 SILICON DR
	SAN ANTONIO, TX 78249
Fiscal Year:	2003
Department:
Project Start:	30-SEP-1999
Project End:	31-JUL-2004
ICD:	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG:	ZRG1

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