In-shoe Pressures Associated With Footwear Fit Guidelines

NCT06025422 | Completed

• 3 other identifiers: edge13694520/0006190273255
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer; Diabetic Neuropathies

Keywords

in-shoe peak plantar pressure; plantar thermal stress response; diabetes footwear fit; toe gap

Outcome Measures

Primary Outcomes (2)

• 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%

Secondary Outcomes (9)

• 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

• 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%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty people with diabetes type 1 or 2 and neuropathy aged between 18 and 80

You may qualify if:

• Men and women aged 18-80 years
• Confirmed diagnosis of diabetes mellitus type 1 or type 2
• Confirmed diagnosis of neuropathy;
• Able to walk unaided for a minimum of 200 steps with capacity to attend the research site
• PAR-Q physical activity questionnaire does not indicate any possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking
• Willingness and capacity to participate in the study and to sign the informed consent form

You may not qualify if:

• Unconfirmed diabetes mellitus diagnosis
• Inability to ambulate independently without walking aids
• Presence of rheumatoid arthritis
• Active ulcer (i.e. having an active ulcer at the time of recruitment)
• Recently healed ulcer (an ulcer which has had less than six months to fully heal)
• History of Charcot in foot/joints
• Previous minor or major amputation
• Neurological disorders other than diabetes-related neuropathy potentially affecting gait, balance or posture
• Blood pressure \>180/100 or \<90/50
• Unable to understand written and verbal English
• PAR-Q physical activity questionnaire indicates possible heart problems, dizziness or other issue indicating unsuitability for mild physical exercise involved in walking

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• University of Salford: collaborator

Study Sites (1)

Leicester Diabetes Centre

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Petra J Jones

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: September 6, 2023
• Study Start: December 15, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

GB (1)