An Apparatus for Testing Devices Used for Determining Protective Foot Sensation U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) The Bureau of Primary Healthcare (BPHC) U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) The Bureau of Primary Healthcare (BPHC) CAPT James Foto, PE, C.Ped USPHS Scientific and Training Symposium Engineer Category Day
Lower Extremity Amputations > 82,000 / year - National Diabetes Fact Sheet, CDC, 2003 “The primary objective of neuropathic foot care is to reduce the epidemic occurrences of lower extremity amputations.”
Discussion Points Loss of Protective SensationLoss of Protective Sensation Monofilament ResearchMonofilament Research Automated Filament Tester (AFT)Automated Filament Tester (AFT) Testing the AFTTesting the AFT
Discussion Points Loss of Protective SensationLoss of Protective Sensation Monofilament ResearchMonofilament Research Automated Filament Tester (AFT)Automated Filament Tester (AFT) Testing the AFTTesting the AFT
“The whole problem is really one of mechanics, not of medicine. The biological responses of these denervated limbs are qualitatively similar to those of normal limbs. It is the permitted pattern of mechanical stress that is different.” Paul W. Brand
Causes of Injury Resulting from Mechanical Stress Acute Trauma likely cause: nails, glass, accidents Ischemia likely cause: tight shoes, foreign objects in shoes, wrinkles in socks or hosiery Repetitive Stress likely cause: normal activities of daily living such as walking Acute Trauma likely cause: nails, glass, accidents Ischemia likely cause: tight shoes, foreign objects in shoes, wrinkles in socks or hosiery Repetitive Stress likely cause: normal activities of daily living such as walking
Loss of Protective Sensation
Discussion Points Loss of Protective SensationLoss of Protective Sensation Monofilament ResearchMonofilament Research Automated Filament Tester (AFT)Automated Filament Tester (AFT) Testing the AFTTesting the AFT
Monofilament Research 1890 – Von Frey used varying thickness horse hair 1960 – Semmes & Weinstein used nylon filament material 1985 – VonPrince, Werner, Omer, Bell, Brand, Buford 1986 – Birke & Sims, HD and DM neuropathic feet 1988 – Bell & Buford, filament repeatability and reliability 1988 – Holewski et al, extent and progression of neuropathy 1989 – Mueller et al, interrater and intrarater reliability 1998 – Birke & Rolfson, Self Administer 2000 – Booth and Young, bench test w/ load cell 2004 – Lawrence et al, filament physical properties and wear 2009 – Feng et al, variation in application methodology
Semmes-Weinstein 5.07 (10g) Monofilament Designed to buckle at 10g forceDesigned to buckle at 10g force
Semmes-Weinstein 5.07 (10g) Monofilament Designed to buckle at 10g forceDesigned to buckle at 10g force Standard device for testing LOPSStandard device for testing LOPS
Semmes-Weinstein 5.07 (10g) Monofilament Designed to buckle at 10g forceDesigned to buckle at 10g force Standard device for testing LOPSStandard device for testing LOPS “Feel” / “no feel” binary response“Feel” / “no feel” binary response
Point of Application Holewski et al, 1988
Discussion Points Loss of Protective SensationLoss of Protective Sensation Monofilament ResearchMonofilament Research Automated Filament Tester (AFT)Automated Filament Tester (AFT) Testing the AFTTesting the AFT
Automated Filament Tester
Bench Top Tester Components 10 gram Load Cell & Signal Conditioner –AL Design ALD-MEGA-10G –Dataforth 8B38 Isolated Strain Gage SG Linear Potentiometer DAQ Programming Language Data Acquisition Device Ball Screw Actuator
Bench Top Tester Components 10 gram Load Cell & Signal Conditioner Linear Potentiometer –Unimeasure LX-PA-3.8 DAQ Programming Language Data Acquisition Device Ball Screw Actuator
Bench Top Tester Components 10 gram Load Cell & Signal Conditioner Linear Potentiometer DAQ Programming Language –National Instruments LabVIEW Data Acquisition Device Ball Screw Actuator
Bench Top Tester Components 10 gram Load Cell & Signal Conditioner Linear Potentiometer DAQ Programming Language Data Acquisition Device –NI USB bit / 48ks/sec Multifxn DAQ Ball Screw Actuator
Bench Top Tester Components 10 gram Load Cell & Signal Conditioner Linear Potentiometer DAQ Programming Language Data Acquisition Device Ball Screw Actuator –Hennkwell PK22G v DC Gear Mtr
Labview Programming
Discussion Points Loss of Protective SensationLoss of Protective Sensation Monofilament ResearchMonofilament Research Automated Filament Tester (AFT)Automated Filament Tester (AFT) Testing the AFTTesting the AFT
Automatic Filament Tester
Output Data
Packaged Filaments
Thank You CAPTJames Foto, PE, C. Ped The National Hansen’s Disease Programs 1770 Physicians Park Dr Baton Rouge, LA (225)