In-shoe Pressures Associated With Footwear Fit Guidelines
Evaluation of Footwear Fit Guidelines Under Pressure in At-Risk Feet
Evaluation of Footwear Fit Guidelines Under Pressure in At-Risk Feet
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Diabetes UK
OTHER · Health Research Authority (IRAS no.)
observational
26
1 country
1
Study Start
December 15, 2022
Actual (reported)Primary Completion
June 30, 2025
Actual (reported)Study Completion
June 30, 2025
Actual (reported)One in five foot ulcers are caused by the footwear worn by people with diabetes, yet there is a lack of consensus around footwear fit. Recommended toe gaps (the gap between the longest toe and the inside of the shoe) vary depending on the footwear guidance referred to but no research to date has assessed the recommendations' effectiveness in minimising in-shoe pressures. The investigators will carry out a pilot study in 60 people with diabetes and loss of foot sensation (neuropathy). In this study, the investigators will measure in-shoe pressures whilst participants walk at the same pace to the beat of a metronome. An insole placed inside participants' shoes will measure in-shoe pressures. Participants will wear the same (standardised) type of footwear. The study is designed to detect a difference in pressure within this made-to-measure footwear whose fit conforms to Standard 1 guidance compared with footwear whose fit conforms to Standard 2 guidance. Differences between Standards 1 and 2 with Standard 3 will be considered secondary analyses. Standards are simplified to three non-overlapping recommended toe gap ranges of 0.5-1.0cm; 1.5-2.0cm and 1.0-1.5cm. The investigators will also analyse the heat images taken with a thermographic camera before and after walking in standardised footwear whose fit confirms to these standards (this is known as the plantar thermal stress response to walking). Footwear fit will be determined by measuring the dimensions of participants' feet and that of participants' footwear and comparing the two. The investigators will also measure footwear fit and associated in-shoe pressure/plantar thermal stress response in participants' habitual footwear during walking at paced and self-selected speeds.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2022
Actual (reported)May 11, 2023
Actual (reported)September 6, 2023
Actual (reported)June 30, 2025
Actual (reported)June 30, 2025
Actual (reported)During the procedure difference in mean in-shoe PPP associated with each toe gap standard within standardised footwear @ regulated pace
During the procedure Difference in the mean average in-shoe peak plantar pressure (PPP) associated with each toe gap standard (measured by Pedar-X pressure monitoring insoles) during walking within standardised footwear at a regulated pace
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure difference in the mean in-shoe PPP by ROI associated with each toe gap standard
During the procedure Mean in-shoe peak plantar pressure (PPP) for each region of interest (ROI) (comprising 10 regions: hallux, toes 2/3, toes 4/5, metatarsal 1, metatarsal 2/3, metatarsal 4/5, medial midfoot, lateral midfoot, medial heel, lateral heel) associated with each toe gap standard during walking within standardised footwear at a regulated pace
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure Exploratory secondary analysis of toe gap Standard 3 in relation to toe gap Standards 1 and 2
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure Pressure time integral & contact area associated with toe gap standards in standardised footwear
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure Proportion of participants with in-shoe PPP > 200 kilopascals in standardised footwear
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
During the procedure PTSR associated with each toe gap standard in standardised footwear
Thermal image taken with FLIR T540-EST thermal camera of plantar surface of feet at rest and after 200 steps within standardised footwear
Sixty people with diabetes type 1 or 2 and neuropathy aged between 18 and 80
Leicester Diabetes Centre
Leicester, Leicestershire, LE5 4PW, United Kingdom
Petra J Jones
University Hospitals, Leicester
26 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2023
First Posted
September 6, 2023
Study Start
December 15, 2022
Actual (reported)Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
During the procedure Mean in-shoe PPP within habitual footwear at a self-selected and regulated pace
During the procedure, peak plantar pressure in kilopascals (kPa) is measured with Novel Pedar pressure measuring insoles and software whilst completing 4 x 12 midgait steps at a speed of 2 miles per hour +/- 5%
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2025
Actual (reported)Study Completion
June 30, 2025
Actual (reported)Last Updated
January 5, 2026
Record last verified: 2025-12
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