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Learning from experience: A simple effective protocol to test footwear prescriptions for the Diabetic foot by using the Pedar system

Adherence of patients to treatment and appropriateness 
of prescribed footwear are mandatory for successful prevention of Diabetic 
foot ulceration. In a Public Healthcare Service, footwear approval is under 
the responsibility of the clinician. In some cases kinetic measurements are 
taken inside the shoes to support the clinical decision; however, an overall 
agreement is still missing with respect to a simple, reliable and effective 
test protocol based on proper threshold values. Authors’ past experiences, 
specific needs of the Diabetic outpatient service, and suggestions from 
valuable literature led to an instrumental test protocol based on reference 
peak pressure (PP) thresholds and gait line (GL) specific for each level of risk. 
Permission was obtained for one preliminary validation session at the Authors’ 
outpatient service, during which 11 patients at high/very high risk of 
ulceration were examined—9 for testing new footwear, 2 for monitoring 
12-month-old footwear. The protocol was well accepted by patients and operators, 
fast and easy to be used. Based on the instrumental, clinical and visual 
inspection data; 4 new footwear did not pass the test; 5 passed the test but 
integration or minor changes were requested; the 2 old footwear were found no 
more effective. As a first positive feedback, after 4 months of wearing the 
modified prescriptions none of the patients had developed plantar ulcers or 
signs of tissue damage. Successive data processing proved that in all patients 
altered PPs and deviated GLs did correlate with alterations of other kinetic 
parameters. The protocol, which is proved to be sensitive and valuable for the Diabetic 
foot care, may have a general validity; the delivered specific PP thresholds 
and reference data, instead, can be reliably used if the test is performed with 
a calibrated Pedar Insole System and with the wide Insoles in the range UW-YW 
(EU size 36 - 45).