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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).
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. The insole comprises a pseudorandom pattern applied to a plastically deformable insole using a temporary tattoo layer. STAMP utilises digital image correlation to track the deformation of the pattern following a period of walking.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Foot Ulcer (DFU) group | Inclusion criteria:
| ||
| Low risk group | Inclusion criteria:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Peak plantar strain | The difference in peak plantar strain (%) (as measured with STAMP) between the DFU and low risk group | At clinical visit on study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Regional peak plantar strain | The difference in regional peak plantar strain (%) between the DFU and low risk group at the 10 pre-specified regions: heel, midfoot, 1st metatarsal head (MTH), 2nd MTH, 3rd MTH, 4th MTH, 5th MTH, hallux, 2nd toe, toes 3-5 | At clinical visit on study entry |
| Regional peak plantar shear |
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DFU group:
Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria.
Inclusion Criteria:
SLIPS inclusion criteria:
Patients will also undergo assessment with the SLIPS insole if they fulfil the following inclusion criteria:
Low risk group:
Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria:
Exclusion Criteria:
SLIPS assessment inclusion:
Exclusion criteria:
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DFU group:
Patients with a recently healed plantar ulcer recruited from a specialised Diabetes Limb Salvage Service in a tertiary referral centre.
Low risk group:
Patients with diabetes and low risk for ulceration recruited from the community podiatry service.
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| Name | Affiliation | Role |
|---|---|---|
| David A Russell | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Oct 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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The difference in regional peak plantar shear (kPa) between the DFU and low risk group at the 10 pre-specified regions: heel, midfoot, 1st metatarsal head (MTH), 2nd MTH, 3rd MTH, 4th MTH, 5th MTH, hallux, 2nd toe, toes 3-5 |
| At clinical visit on study entry |
| Peak Plantar pressure | Global peak plantar pressure (kPa) between DFU and low risk groups. | At clinical visit on study entry |
| Regional Peak Plantar pressure | Regional peak plantar pressure (kPa) between DFU and low risk groups | At clinical visit on study entry |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |