Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
NCT ID: NCT05687643
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-07-01
2024-04-03
Brief Summary
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Detailed Description
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Shear Load Inductive Plantar Sensing (SLIPS) is an insole designed by the University of Leeds to measure plantar shear stress and plantar pressure. SLIPS is an insole which integrates 64 tri-axis soft force sensors which simultaneously measures shear stress and pressure. The SLIPS insole has been designed to measure the plantar load of the right foot and due to its size can only be accommodated by a size 8-11 shoe.
The commercial device Pedar (Novel gmbh) will be used as a reference for plantar pressure measurement in both groups.
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).
It is hypothesised that patients with a recently healed plantar ulcer with exhibit elevated plantar strain, plantar shear stress and plantar pressure than the low risk group.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Diabetic Foot Ulcer (DFU) group
Inclusion criteria:
1. Age \>18
2. A diagnosis of diabetes mellitus
3. A diagnosis of diabetic peripheral neuropathy
4. Recently healed plantar ulcer (within the last 3 months)
No interventions assigned to this group
Low risk group
Inclusion criteria:
1. Age \>18
2. A diagnosis of diabetes mellitus
3. Low risk for DFU according to the NG19 guidelines (no risk factors for ulceration except callus alone)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of diabetes mellitus
3. A diagnosis of diabetic peripheral neuropathy
4. Recently healed plantar ulcer (within the last 3 months)
5. Able to provide informed consent
6. Previous open or endovascular revascularisation
1. Recently healed plantar DFU located on the right foot
2. The right foot can be accommodated in a size 8-11 shoe
3. Weight \<100kg
Low risk group:
Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria:
1. Age \>18
2. A diagnosis of diabetes mellitus
3. Low risk for DFU according to the NICE NG 19 guidelines (no risk factors for ulceration except callus alone)
4. Able to provide informed consent
Exclusion Criteria
2. Previous ipsilateral minor amputation
3. Previous ipsilateral surgical offloading procedure
4. Previous contralateral major amputation
5. Ipsilateral toe pressure \<40mmHg
SLIPS assessment inclusion:
1. The right foot can be accommodated in a size 8-11 shoe
2. Weight \<100kg
1. Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
2. Previous ipsilateral minor amputation
3. Presence of a foot deformity
4. Previous contralateral major amputation
5. Ipsilateral toe pressure \<40mmHg
18 Years
ALL
No
Sponsors
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The Leeds Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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David A Russell
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VS21/143856
Identifier Type: -
Identifier Source: org_study_id
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