This program will develop and test a novel device that is capable of detailed monitoring and data logging of pressures applied to the foot of diabetic patients during daily activities. The device is intended to be used by a health care practitioner, such as a pedorthotist or orthotist, whose objective is to prevent foot ulcerations by reducing the repetitive stress applied daily to high risk areas of the plantar surface (e.g., heels) of diabetic patients with loss of protective sensation. The proposed device will be a quantitative tool that provides valuable detailed information regarding the applied local pressures to the diabetic foot on a step by step basis during several weeks of normal activities. A data base will also be created to store such data to provide physicians an enhanced source for information on diabetic foot care. It also provides a percent efficacy quantitative measure of orthoses. The ultimate goal is to reduce the tragedy of limb amputations resulting from diabetic foot ulcerations. The Diabetic Foot Pressure Monitor is capable of detailed on-line monitoring and logging of repetitive stress exerted to high risk areas of the plantar surface of the foot of diabetic patients with no protective sensation. It also records information about pressures exerted at each time and in every step taken for up to three weeks of normal daily activities (one week in Phase I), to provide the clinician a record of patient progress with the prescribed treatment protocol. This will provide data for improved, more quantitative treatment strategies. A reduction in the number of diabetic foot ulcers would save several hundred million dollars per year in the US alone. The Diabetic Foot Pressure Monitor would also decrease emotional stress in the diabetic community and their families, and eliminate the loss of mobility and productivity that results from amputation.

Proposed Commercial Applications

NOT AVAILABLE

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 I (R43)
Project #
1R43DK051929-01A2
Application #
2645389
Study Section
Special Emphasis Panel (ZRG4-SSS-5 (16))
Program Officer
Garfield, Sanford A
Project Start
1998-08-15
Project End
2000-01-31
Budget Start
1998-08-15
Budget End
2000-01-31
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Cleveland Medical Devices, Inc.
Department
Type
DUNS #
City
Cleveland
State
OH
Country
United States
Zip Code
44103