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Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration
Sponsor: The Leeds Teaching Hospitals NHS Trust
Summary
This single-centre observational case-control study investigates how peripheral arterial disease influences plantar load in people with diabetes who have recently healed a plantar foot ulcer. Using in-shoe pressure mapping (Pedar™) and 3D digital image correlation of a plasticine deformable insole (STAMPS system), we will quantify vertical pressure and strain magnitude. Weight-bearing ultrasound will assess plantar fat-pad thickness as a potential corollary for forefoot peak pressure and shear. All procedures are non-invasive and completed in a single \~90-minute visit at Leeds Teaching Hospitals NHS Trust.
Official title: Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration (PLANE-DFU): Investigating Plantar Pressure and Shear in Neuropathic Versus Neuroischaemic Diabetes-Related Foot Ulceration
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
16
Start Date
2025-10-25
Completion Date
2026-04-01
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Pedar™ In-Shoe Plantar Pressure Measurement System
The Pedar™ system (Novel GmbH, Munich, Germany) is a validated in-shoe pressure mapping platform comprising thin flexible insoles embedded with capacitive sensors. It measures vertical plantar pressure distribution during walking. In this study, participants wear the insoles inside standardised footwear while walking 10 steps at a self-selected pace to quantify peak pressure and pressure-time integrals across defined foot regions.
STAMPS 3D Digital Image Correlation System
The STAMPS (Strain Analysis and Mapping of the Plantar Surface) platform uses 3D Digital Image Correlation to quantify deformation of a plastically deformable speckled insole during walking. Participants wear a soft boot containing the STAMPS insole and walk approximately ten steps at normal speed. This technique captures both vertical and tangential (shear) strain, providing spatial maps of plantar shear during gait.
Weight-Bearing Ultrasound of the Plantar Fat Pad
High-frequency ultrasound is used to measure the thickness of the plantar fat pad under weight-bearing conditions. Participants stand barefoot on a transparent polymethyl methacrylate (Plexiglass) platform while the transducer is applied from beneath to obtain cross-sectional images of the forefoot at the level of each metatarsal head. The measurement provides structural information about plantar soft-tissue thickness as a proxy measure for plantar fat pad thickness.
Locations (1)
Leeds Teaching Hospitals Nhs Trust
Leeds, England - Midlands and East, United Kingdom