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Completed
NCT07901478
Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration
Conditions: Foot Ulcers, Diabetic, Plantar Foot Pressure, Fat Pad Atrophy, Peripheral Arterial Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 16
Sponsor: The Leeds Teaching Hospitals NHS Trust
Location: Leeds Teaching Hospitals Nhs Trust Leeds England - Midlands and East
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.
Eligibility Criteria
Inclusion Criteria:
* Age \> 18 years
* Confirmed diabetes mellitus (type 1 or 2)
* Recently healed plantar DFU (forefoot, \
Source: ClinicalTrials.gov (NCT07901478). StuddyBuddy aggregates publicly available trial information.