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

Abstract

<p> <span style="font-size:10pt;font-family:Verdana;">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)</span><span style="font-size:10pt;font-family:Verdana;">. </span><span style="line-height:1.5;font-family:Verdana;"></span> </p

In-shoe pressure thresholds for people with diabetes and neuropathy at risk of ulceration: A systematic review

“…The evidence of the effectiveness of these in-shoe pressure threshold is limited to just four studies [34,37,41,48], consisting of two non-RCT cohort studies [41,48] and one RCT [34] relating to the 200 kPa threshold and one RCT relating to the 35 mmHG threshold [37]. The majority of these studies are non-RCT (n=17) [22,33,35,36,[38][39][40][41][42][43][44][45][46][48][49][50][51] concerned with the feasibility of various mechanisms of pressure reduction within the threshold target or as a benchmark for evaluating multiple interventions e.g. rival insoles or footwear designs.…”

“…To date, only one study has evaluated retention of these walking strategies beyond ten days, where only 50% achieved the required maximum pressure threshold in a small non-RCT cohort with just 11 participants [52]. Equally the suggested approach of a matrix of different thresholds providing thresholds for four regions (toes, forefoot, midfoot and rearfoot) based on both an individual's risk level and shoe size [49] has yet to be formally assessed against ulceration rates or days spent in remission. This protocol was derived from a validation session of only 11 participants with diabetes and neuropathy who were provided with modified prescription footwear and followed for only four months.…”

“…(2) the level of risk (level 0 = no neuropathy, history of ulceration or foot deformity, 1 = neuropathy but no deformity or history of ulceration; 2 = neuropathy and deformity but no history of ulceration or 3 = neuropathy, deformity and a history of ulceration) and ( 3) individual shoe size [49]. The suggested thresholds were based on reference in-shoe pressures obtained during walking in semi-rigid Terapes shoes with Pedar-X insoles for 20 healthy volunteers and 11 participants with diabetes and neuropathy.…”

Preservation of gait biomechanics during offloading treatment of diabetic foot ulcers

“…The assessment protocol was applied to a healthy volunteer (F; 41years; BMI 19; high forefoot pressures; negligible foot extra-rotation; used to walk fast): 10 consistent footsteps per foot were simultaneously acquired by the two systems when the subject hit the platform; a high cadence of 110 steps per minute was acoustically imposed; the subject was acquired while walking barefoot (B), with primary prevention flexible shoes (F), with secondary prevention rigid shoes (R), with the OPTIMA DIAB without offloading (O), and with the OPTIMA DIAB with right central forefoot offloading (OS1). Pressure footprints were divided into 4 major regions [ 2 ]. All relevant parameters were averaged, with force and COP curves resampled before averaging.…”

Unobtrusive and Continuous Monitoring of Alcohol-impaired Gait Using Smart Shoes

“…This improvement in classifier performance results from the specific information on initial and terminal contact that can be extracted from pressure data independent of the pattern and speed of gait [32,52,53]. The medical application of pressure-based gait monitoring has been also demonstrated in [17,36,47].…”