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Abstract

Grant Number:	1R43DK063768-01A1
PI Name:	TARLER, MATTHEW D.
PI Email:	mtarler@clevemed.com
PI Title:
Project Title:	Clinical Step Recorder

Abstract: DESCRIPTION (provided by applicant): Patients with diabetes mellitus (DM) and peripheral neuropathy (PN) are at high risk for lower extremity skin breakdown and subsequent amputation. Magnitude and repetition of pressures are important indicators of skin breakdown and formation of neuropathic ulcers. Currently, there are no devices that can easily and unobtrusively measure the repetition of pressures and total weight-bearing time over a prolonged period of time (e.g., 2 weeks). The most common method of treatment of these neuropathic ulcers is off loading weight over the ulcer site using a total contact cast (TCC) or an ankle foot orthosis (AFO). The primary purpose of this grant proposal is to develop an unobtrusive, self-contained, inexpensive device that can fit inside a shoe, cast, or AFO, that will record and time stamp steps, average pressures, and weight-bearing time for "at-dsiC patients for extended periods of time. The completed Clinical Step Recorder (CSR) system will be validated with patients currently using a TCC, and subjects wearing shoes with orthotic inserts. The CSR device will have many other uses, including that of an activity monitor for patients with obesity, or the elderly, which could help assess weight-bearing activities and encourage regular physical activities.

Thesaurus Terms:
biomedical equipment development, diabetic neuropathy, electronic recording system, foot, gait, patient monitoring device, skin ulcer
computer program /software, computer system design /evaluation, mechanical pressure, miniature biomedical equipment, portable biomedical equipment
clinical research, human subject

Institution:	CLEVELAND MEDICAL DEVICES, INC.
	11000 CEDAR AVE, STE 130/461
	CLEVELAND, OH 44106
Fiscal Year:	2003
Department:
Project Start:	01-SEP-2003
Project End:	31-AUG-2004
ICD:	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
IRG:	ZRG1

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