Clincosm LogoSign in Get a demo

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

Sponsor
The Leeds Teaching Hospitals NHS Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05687643
Collaborator
(none)
60
Enrollment
1
Location
9.1
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Apr 3, 2023
    Anticipated Study Completion Date :
    Apr 3, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Peak plantar strain [At clinical visit on study entry]

      The difference in peak plantar strain (%) (as measured with STAMP) between the DFU and low risk group

    Secondary Outcome Measures

    1. Regional peak plantar strain [At clinical visit on study entry]

      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

    2. Regional peak plantar shear [At clinical visit on study entry]

      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

    3. Peak Plantar pressure [At clinical visit on study entry]

      Global peak plantar pressure (kPa) between DFU and low risk groups.

    4. Regional Peak Plantar pressure [At clinical visit on study entry]

      Regional peak plantar pressure (kPa) between DFU and low risk groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire United Kingdom LS9 7TF

    Sponsors and Collaborators

    • The Leeds Teaching Hospitals NHS Trust

    Investigators

    • Principal Investigator: David A Russell, University of Leeds

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    The Leeds Teaching Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT05687643
    Other Study ID Numbers:
    • VS21/143856
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetic Foot
    Foot Ulcer
    Ulcer

    Study Results

    No Results Posted as of Jan 18, 2023