Patients with diabetes mellitus (DM) and peripheral neuropathy (PN) are at high risk for lower extremity skin breakdown and subsequent amputation. Excessive stresses applied to insensitive skin during normal walking, constitutes a primary contributing factor to skin breakdown. Recent literature advocates an optimal window of stress for tissue maintenance or strengthening, above or below which leads to tissue damage. The goal of this proposal is to develop instrumentation to measure, record, analyze, and provide feedback regarding vertical forces, temperature, and humidity on the plantar surface of the foot during prolonged functional activities. A data collection unit (DCU), located within the shoe, will collect, analyze, and store the data, and transmit information to the patient feedback unit (FBU) via a radio frequency (RF) link. The DCU will also download the data to a computer that will transmit the data to a central database for further analysis. The long-term goal of this research will be to determine the optimal window of stress and then ultimately prevent skin breakdown and amputation through real-time feedback and warnings to patients. This device usage may also be extended to elderly or obese patients, or for testing efficacy and efficiency of various footwear or orthotic devices.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD044426-01
Application #
6645233
Study Section
Special Emphasis Panel (ZRG1-SSS-5 (10))
Program Officer
Shinowara, Nancy
Project Start
2003-05-01
Project End
2005-10-31
Budget Start
2003-05-01
Budget End
2005-10-31
Support Year
1
Fiscal Year
2003
Total Cost
$99,999
Indirect Cost
Name
Cleveland Medical Devices, Inc.
Department
Type
DUNS #
557510625
City
Cleveland
State
OH
Country
United States
Zip Code
44103