Diabetic FootSLIPSTREAMNCT05687643
Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
An observational study of Diabetic Foot and Diabetic Foot Ulcer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 3 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >18
- A diagnosis of diabetes mellitus
- A diagnosis of diabetic peripheral neuropathy
- Recently healed plantar ulcer (within the last 3 months)
- Able to provide informed consent
- Previous open or endovascular revascularisation
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- SLIPS 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 foot
- The right foot can be accommodated in a size 8-11 shoe
- Weight <100kg
- Low risk group:
- Patients will undergo STAMP and Pedar assessment if they fulfil the following criteria:
- Age >18
- A diagnosis of diabetes mellitus
- Low risk for DFU according to the NICE NG 19 guidelines (no risk factors for ulceration except callus alone)
- Able to provide informed consent
Who cannot join
- Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
- Previous ipsilateral minor amputation
- Previous ipsilateral surgical offloading procedure
- Previous contralateral major amputation
- Ipsilateral toe pressure <40mmHg
- SLIPS assessment inclusion:
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- The right foot can be accommodated in a size 8-11 shoe
- Weight <100kg
- Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
- Previous ipsilateral minor amputation
- Presence of a foot deformity
- Previous contralateral major amputation
- Ipsilateral toe pressure <40mmHg
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
About this study
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).
Read the 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.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plantar strain
The difference in peak plantar strain (%) (as measured with STAMP) between the DFU and low risk group
Measured: At clinical visit on study entry
Secondary outcomes (4)
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
Measured: 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
Measured: At clinical visit on study entry
Peak Plantar pressure
Global peak plantar pressure (kPa) between DFU and low risk groups.
Measured: At clinical visit on study entry
Regional Peak Plantar pressure
Regional peak plantar pressure (kPa) between DFU and low risk groups
Measured: At clinical visit on study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jul 2022
- Primary completion3 Apr 2024 (estimated)
- Study completion3 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A Russell, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687643
- Sponsor's protocol ID
- VS21/143856
- Acronym
- SLIPSTREAM
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05687643
- Acronym / sponsor ID
- SLIPSTREAM / VS21/143856
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 3 Apr 2024 (estimated)
- Study completion
- 3 Apr 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- Age >18
- A diagnosis of diabetes mellitus
- A diagnosis of diabetic peripheral neuropathy
- Recently healed plantar ulcer (within the last 3 months)
- Able to provide informed consent
Key exclusion criteria (13 listed)
- Unable to mobilise independently 150m without the use of walking aids and thus unable to complete the walking assessments
- Previous ipsilateral minor amputation
- Previous ipsilateral surgical offloading procedure
- Previous contralateral major amputation
- Ipsilateral toe pressure <40mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak plantar strain
Time frame: At clinical visit on study entry
The difference in peak plantar strain (%) (as measured with STAMP) between the DFU and low risk group
4 secondary outcomes
Regional peak plantar strain
Time frame: At clinical visit on study entry
Regional peak plantar shear
Time frame: At clinical visit on study entry
Peak Plantar pressure
Time frame: At clinical visit on study entry
Regional Peak Plantar pressure
Time frame: At clinical visit on study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Russell principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetic Foot Ulcer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plantar strain (time frame: At clinical visit on study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.