An observational study in Foot Ulcers, Diabetic, Plantar Foot Pressure and Fat Pad Atrophy, sponsored by The Leeds Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
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.
Diabetes-related foot ulceration (DFU) is associated with a high risk of recurrence following healing. Although peripheral neuropathy and abnormal plantar loading are established contributors to ulceration, the extent to which concomitant peripheral arterial disease (PAD) is associated with differences in plantar pressure and shear-related deformation remains poorly understood. Structural changes in the plantar fat pad may contribute to altered load distribution, although this relationship has not been established.
The PLANE-DFU study is a single-centre observational case-control investigation comparing plantar loading characteristics between individuals with recently healed neuropathic and neuroischaemic DFU. Participants are classified according to neurological assessment, pedal vascular examination, toe pressure measurements and previous revascularisation history. The study aims to characterise associations between vascular phenotype, plantar loading and plantar fat-pad structure.
Plantar pressure is measured during walking using the Pedar™ in-shoe pressure measurement system. Plantar strain is assessed using the STAMPS3D system, which employs a plastically deformable insole with an applied speckle pattern. Stereoscopic images obtained before and after walking are processed using three-dimensional digital image correlation to reconstruct displacement and strain fields, including components associated with tangential loading. Repeated walking assessments are performed using both systems.
Plantar fat-pad thickness is assessed under weight-bearing conditions using sagittal ultrasonography through a custom ultrasound-compatible platform. Measurements are obtained in triplicate beneath each metatarsal head. These structural measurements are examined in relation to regional plantar loading characteristics to explore whether differences in fat-pad thickness are associated with pressure and strain distribution across the neuropathic and neuroischaemic groups.
196 studies on the registry are indexed under Foot Ulcer; 44 are open to participants now.
This study's enrollment of 16 is below the median of 84 across 26 observational studies indexed under Foot Ulcer.
Browse Foot Ulcer studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals with diabetes who have recently healed (\<3 months) a diabetes-related foot ulcer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with diabetes and a recently healed plantar forefoot (\<3 months) ulcer caused by neuropathic ulceration in the presence of preserved perfusion. Sensory neuropathy is confirmed by insensitivity to the 10 g monofilament (Ipswich Touch Test). Participants have at least one palpable pedal pulse and at least one multiphasic pedal Doppler signal, with opening toe pressure ≥ 60 mmHg. No history of lower-limb revascularisation.
Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System · Diagnostic Test: STAMPS 3D Digital Image Correlation System · Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat Pad
Participants with diabetes and a recently healed plantar forefoot (\<3 months) of neuroischaemic aetiology, showing both sensory neuropathy and peripheral arterial disease. PAD is defined as a prior revascularisation procedure or by the absence of pedal pulses and monophasic or absent Doppler signal with an opening toe pressure ≤ 50 mmHg.
Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System · Diagnostic Test: STAMPS 3D Digital Image Correlation System · Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat Pad
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.
Also known as: Pedar; Novel Pedar System; In-shoe pressure analysis
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.
Also known as: STAMPS; Strain Analysis and Mapping of the Plantar Surface; 3D DIC plantar shear measurement
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.
Also known as: Plantar ultrasound; Ultrasound fat-pad assessment; Weight-bearing plantar imaging
Difference in mean peak plantar pressure and peak shear strain between neuropathic and neuroischaemic cohorts
Quantitative comparison of plantar load between neuropathic and neuroischaemic diabetic foot ulcer groups. Mean peak plantar pressure (kPa) will be derived from in-shoe Pedar™ measurements, and mean peak plantar shear strain (SMag) will be obtained from 3D Digital Image Correlation (STAMPS) analysis. Data will be collected during a single walking trial at the study visit and expressed as regional and whole-foot means. The primary analysis will evaluate between-group differences in these parameters using linear regression to determine the effect of peripheral arterial disease on plantar loading.
Time frame: Baseline (single 90-minute assessment visit)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The decision regarding IPD sharing will be made after study completion in consultation with the University of Leeds (sponsor) and Leeds Teaching Hospitals NHS Trust. Anonymised datasets may be deposited in the University's Research Data Repository if deemed appropriate and compliant with data governance and participant consent provisions.
Ran from Oct 2025 to primary completion in Apr 2026, 5 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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