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NCT05687643
Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
Conditions: Diabetic Foot, Diabetic Foot Ulcer
Sex: All
Ages: 18 Years – N/A
Enrollment: 60
Sponsor: The Leeds Teaching Hospitals NHS Trust
Location: United Kingdom
Summary
Stain Analysis Mapping of the Plantar surface (STAMP) is a method designed by the University of Leeds to measure 'in-shoe' strain patterns on the plantar surface of the foot.
Shear Load Inductive Plantar Sensing (SLIPS) is an insole designed by the University of Leeds to measure plantar shear stress and plantar pressure.
This study aims to compare plantar strain using STAMP and plantar shear stress and plantar pressure using SLIPS in two groups of patients with diabetes; high risk patients with a recently healed plantar ulcer and low risk patients (according to the NICE definition).
Eligibility Criteria
DFU group:Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria.Inclusion Criteria:Age >18A diagnosis of diabetes mellitusA diagnosis of diabetic peripheral neuropathyRecently healed plantar ulcer (within the last 3 months)Able to provide informed consentPrevious open or endovascular revascularisationSLIPS inclusion criteria:Patients will also undergo assessment with the SLIPS insole if they fulfil the following inclusion criteria:Recently healed plantar DFU located on the right footThe right foot can be accommodated in a size 8-11 shoeWeight <100kgLow risk group:Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria:Age >18A diagnosis of diabetes mellitusLow risk for DFU according to the NICE NG 19 guidelines (no risk factors for ulceration except callus alone)Able to provide informed consentExclusion Criteria:Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessmentsPrevious ipsilateral minor amputationPrevious ipsilateral surgical offloading procedurePrevious contralateral major amputationIpsilateral toe pressure <40mmHgSLIPS assessment inclusion:The right foot can be accommodated in a size 8-11 shoeWeight <100kgExclusion criteria:Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessmentsPrevious ipsilateral minor amputationPresence of a foot deformityPrevious contralateral major amputationIpsilateral toe pressure <40mmHg
Source: ClinicalTrials.gov (NCT05687643). StuddyBuddy aggregates publicly available trial information.