Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers (SLIPSTREAM)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot; Diabetic Foot Ulcer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

DFU group:

Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria.

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)
5. Able to provide informed consent
6. Previous open or endovascular revascularisation

SLIPS inclusion criteria:

Patients will also undergo assessment with the SLIPS insole if they fulfil the following inclusion criteria:

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:

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. 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Diabetic Foot Ulcer (DFU) group; Inclusion criteria: Age >18; A diagnosis of diabetes mellitus; A diagnosis of diabetic peripheral neuropathy; Recently healed plantar ulcer (within the last 3 months)
Low risk group; Inclusion criteria: Age >18; A diagnosis of diabetes mellitus; Low risk for DFU according to the NG19 guidelines (no risk factors for ulceration except callus alone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: David A Russell, University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): April 3, 2024
• Study Completion (Estimated): April 3, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: VS21/143856

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No