Foot Ulcers, DiabeticPLANE-DFUNCT07901478
Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration
An observational study of Foot Ulcers, Diabetic and Plantar Foot Pressure, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This single-centre observational case-control study investigates how peripheral arterial disease influences plantar load in people with diabetes who have recently healed a plantar foot ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcers, Diabetic, Plantar Foot Pressure, Fat Pad Atrophy
- What is being tested?
- Pedar™ In-Shoe Plantar Pressure Measurement System, STAMPS 3D Digital Image Correlation System and Weight-Bearing Ultrasound of the Plantar Fat Pad
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2025to 1 Apr 2026
- 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: Individuals with diabetes who have recently healed (<3 months) a diabetes-related foot ulcer.
Who may be able to join
- Age > 18 years
- Confirmed diabetes mellitus (type 1 or 2)
- Recently healed plantar DFU (forefoot, <3months)
- Able to walk 10m unaided
- Able to provide written consent
Who cannot join
- Active ulceration or infection
- Hindfoot or non-plantar ulcer location
- Non-diabetic aetiology
- Previous ipsilateral minor amputation or contralateral major lower limb amputation
- Need for a walking aid
- Inability to understand English instructions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals Nhs Trust
Leeds, England - Midlands and East, LS9 7TF
About this study
Official title: Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration (PLANE-DFU): Investigating Plantar Pressure and Shear in Neuropathic Versus Neuroischaemic Diabetes-Related Foot Ulceration
This single-centre observational case-control study investigates how peripheral arterial disease influences plantar load in people with diabetes who have recently healed a plantar foot ulcer. Using in-shoe pressure mapping (Pedar™) and 3D digital image correlation of a plasticine deformable insole (STAMPS system), we will quantify vertical pressure and strain magnitude. Weight-bearing ultrasound will assess plantar fat-pad thickness as a potential corollary for forefoot peak pressure and shear. All procedures are non-invasive and completed in a single ~90-minute visit at Leeds Teaching Hospitals NHS Trust.
Read the detailed description
Diabetes-related foot ulceration (DFU) is associated with a high risk of recurrence following healing. Although peripheral neuropathy and abnormal plantar loading are established contributors to ulceration, the extent to which concomitant peripheral arterial disease (PAD) is associated with differences in plantar pressure and shear-related deformation remains poorly understood. Structural changes in the plantar fat pad may contribute to altered load distribution, although this relationship has not been established.
The PLANE-DFU study is a single-centre observational case-control investigation comparing plantar loading characteristics between individuals with recently healed neuropathic and neuroischaemic DFU. Participants are classified according to neurological assessment, pedal vascular examination, toe pressure measurements and previous revascularisation history. The study aims to characterise associations between vascular phenotype, plantar loading and plantar fat-pad structure.
Plantar pressure is measured during walking using the Pedar™ in-shoe pressure measurement system. Plantar strain is assessed using the STAMPS3D system, which employs a plastically deformable insole with an applied speckle pattern. Stereoscopic images obtained before and after walking are processed using three-dimensional digital image correlation to reconstruct displacement and strain fields, including components associated with tangential loading. Repeated walking assessments are performed using both systems.
Plantar fat-pad thickness is assessed under weight-bearing conditions using sagittal ultrasonography through a custom ultrasound-compatible platform. Measurements are obtained in triplicate beneath each metatarsal head. These structural measurements are examined in relation to regional plantar loading characteristics to explore whether differences in fat-pad thickness are associated with pressure and strain distribution across the neuropathic and neuroischaemic groups.
- Conditions
- Foot Ulcers, Diabetic, Plantar Foot Pressure, Fat Pad Atrophy, Peripheral Arterial Disease
- Being tested
- Pedar™ In-Shoe Plantar Pressure Measurement System, STAMPS 3D Digital Image Correlation System, Weight-Bearing Ultrasound of the Plantar Fat Pad
- Keywords
- Plantar fat pad
- Medical subject headings
- Foot Ulcer, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedar™ In-Shoe Plantar Pressure Measurement SystemDiagnostic test
Also called Pedar; Novel Pedar System; In-shoe pressure analysis
The Pedar™ system (Novel GmbH, Munich, Germany) is a validated in-shoe pressure mapping platform comprising thin flexible insoles embedded with capacitive sensors. It measures vertical plantar pressure distribution during walking. In this study, participants wear the insoles inside standardised footwear while walking 10 steps at a self-selected pace to quantify peak pressure and pressure-time integrals across defined foot regions.
STAMPS 3D Digital Image Correlation SystemDiagnostic test
Also called STAMPS; Strain Analysis and Mapping of the Plantar Surface; 3D DIC plantar shear measurement
The STAMPS (Strain Analysis and Mapping of the Plantar Surface) platform uses 3D Digital Image Correlation to quantify deformation of a plastically deformable speckled insole during walking. Participants wear a soft boot containing the STAMPS insole and walk approximately ten steps at normal speed. This technique captures both vertical and tangential (shear) strain, providing spatial maps of plantar shear during gait.
Weight-Bearing Ultrasound of the Plantar Fat PadDiagnostic test
Also called Plantar ultrasound; Ultrasound fat-pad assessment; Weight-bearing plantar imaging
High-frequency ultrasound is used to measure the thickness of the plantar fat pad under weight-bearing conditions. Participants stand barefoot on a transparent polymethyl methacrylate (Plexiglass) platform while the transducer is applied from beneath to obtain cross-sectional images of the forefoot at the level of each metatarsal head. The measurement provides structural information about plantar soft-tissue thickness as a proxy measure for plantar fat pad thickness.
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic Diabetes-related Foot Ulcer (DFU) Cohort | Participants with diabetes and a recently healed plantar forefoot (<3 months) ulcer caused by neuropathic ulceration in the presence of preserved perfusion. Sensory neuropathy is confirmed by insensitivity to the 10 g monofilament (Ipswich Touch Test). Participants have at least one palpable pedal pulse and at least one multiphasic pedal Doppler signal, with opening toe pressure ≥ 60 mmHg. No history of lower-limb revascularisation. Receives: Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System; Diagnostic Test: STAMPS 3D Digital Image Correlation System; Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat Pad | |
| Neuroischaemic Diabetes-related Foot Ulcer (DFU) Cohort | Participants with diabetes and a recently healed plantar forefoot (<3 months) of neuroischaemic aetiology, showing both sensory neuropathy and peripheral arterial disease. PAD is defined as a prior revascularisation procedure or by the absence of pedal pulses and monophasic or absent Doppler signal with an opening toe pressure ≤ 50 mmHg. Receives: Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System; Diagnostic Test: STAMPS 3D Digital Image Correlation System; Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean peak plantar pressure and peak shear strain between neuropathic and neuroischaemic cohorts
Quantitative comparison of plantar load between neuropathic and neuroischaemic diabetic foot ulcer groups.
Mean peak plantar pressure (kPa) will be derived from in-shoe Pedar™ measurements, and mean peak plantar shear strain (SMag) will be obtained from 3D Digital Image Correlation (STAMPS) analysis.
Data will be collected during a single walking trial at the study visit and expressed as regional and whole-foot means.
The primary analysis will evaluate between-group differences in these parameters using linear regression to determine the effect of peripheral arterial disease on plantar loading.
Measured: Baseline (single 90-minute assessment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start25 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcers, DiabeticStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901478
- Sponsor's protocol ID
- VS25/180008
- Other IDs
- 355867, 25/SC/0253
- Acronym
- PLANE-DFU
- Status last verified
- Oct 2025
- First submitted
- 19 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding IPD sharing will be made after study completion in consultation with the University of Leeds (sponsor) and Leeds Teaching Hospitals NHS Trust. Anonymised datasets may be deposited in the University's Research Data Repository if deemed appropriate and compliant with data governance and participant consent provisions.
Publications
Sairally F, Turnbull RP, Siddle HJ, Russell DA, Brockett C, Culmer PR. Development and evaluation of a novel 3D in-shoe plantar strain measurement system: STAMPS3D. Proc Inst Mech Eng H. 2025 May;239(5):472-484. doi: 10.1177/09544119251330738. Epub 2025 Apr 12.
PubMed 40219920Crossland SR, Siddle HJ, Brockett CL, Culmer P. Evaluating the use of a novel low-cost measurement insole to characterise plantar foot strain during gait loading regimes. Front Bioeng Biotechnol. 2023 Aug 17;11:1187710. doi: 10.3389/fbioe.2023.1187710. eCollection 2023.
PubMed 37662427Jones AD, Crossland SR, Nixon JE, Siddle HJ, Russell DA, Culmer PR. STrain Analysis and Mapping of the Plantar Surface (STAMPS): A novel technique of plantar load analysis during gait. Proc Inst Mech Eng H. 2023 Jul;237(7):841-854. doi: 10.1177/09544119231181797. Epub 2023 Jun 24.
PubMed 37353979Pitei DL, Lord M, Foster A, Wilson S, Watkins PJ, Edmonds ME. Plantar pressures are elevated in the neuroischemic and the neuropathic diabetic foot. Diabetes Care. 1999 Dec;22(12):1966-70. doi: 10.2337/diacare.22.12.1966.
PubMed 10587827
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Load Analysis of Neuropathic and Neuroischaemic Diabetes-Related Foot Ulceration (PLANE-DFU): Investigating Plantar Pressure and Shear in Neuropathic Versus Neuroischaemic Diabetes-Related Foot Ulceration
- ClinicalTrials.gov ID
- NCT07901478
- Acronym / sponsor ID
- PLANE-DFU / VS25/180008
- Conditions
- Foot Ulcers, Diabetic, Plantar Foot Pressure, Fat Pad Atrophy, Peripheral Arterial Disease
- Keywords
- Plantar fat pad
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 28 Oct 2026 (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.
This single-centre observational case-control study investigates how peripheral arterial disease influences plantar load in people with diabetes who have recently healed a plantar foot ulcer. Using in-shoe pressure mapping (Pedar™) and 3D digital image correlation of a plasticine deformable insole (STAMPS system), we will quantify vertical pressure and strain magnitude. Weight-bearing ultrasound will assess plantar fat-pad thickness as a potential corollary for forefoot peak pressure and shear. All procedures are non-invasive and completed in a single ~90-minute visit at Leeds Teaching Hospitals NHS Trust.
Detailed description
Diabetes-related foot ulceration (DFU) is associated with a high risk of recurrence following healing. Although peripheral neuropathy and abnormal plantar loading are established contributors to ulceration, the extent to which concomitant peripheral arterial disease (PAD) is associated with differences in plantar pressure and shear-related deformation remains poorly understood. Structural changes in the plantar fat pad may contribute to altered load distribution, although this relationship has not been established.
The PLANE-DFU study is a single-centre observational case-control investigation comparing plantar loading characteristics between individuals with recently healed neuropathic and neuroischaemic DFU. Participants are classified according to neurological assessment, pedal vascular examination, toe pressure measurements and previous revascularisation history. The study aims to characterise associations between vascular phenotype, plantar loading and plantar fat-pad structure.
Plantar pressure is measured during walking using the Pedar™ in-shoe pressure measurement system. Plantar strain is assessed using the STAMPS3D system, which employs a plastically deformable insole with an applied speckle pattern. Stereoscopic images obtained before and after walking are processed using three-dimensional digital image correlation to reconstruct displacement and strain fields, including components associated with tangential loading. Repeated walking assessments are performed using both systems.
Plantar fat-pad thickness is assessed under weight-bearing conditions using sagittal ultrasonography through a custom ultrasound-compatible platform. Measurements are obtained in triplicate beneath each metatarsal head. These structural measurements are examined in relation to regional plantar loading characteristics to explore whether differences in fat-pad thickness are associated with pressure and strain distribution across the neuropathic and neuroischaemic groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropathic Diabetes-related Foot Ulcer (DFU) Cohort | – | Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System, Diagnostic Test: STAMPS 3D Digital Image Correlation System, Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat PadParticipants with diabetes and a recently healed plantar forefoot (<3 months) ulcer caused by neuropathic ulceration in the presence of preserved perfusion. Sensory neuropathy is confirmed by insensitivity to the 10 g monofilament (Ipswich Touch Test). Participants have at least one palpable pedal pulse and at least one multiphasic pedal Doppler signal, with opening toe pressure ≥ 60 mmHg. No history of lower-limb revascularisation. |
| Neuroischaemic Diabetes-related Foot Ulcer (DFU) Cohort | – | Diagnostic Test: Pedar™ In-Shoe Plantar Pressure Measurement System, Diagnostic Test: STAMPS 3D Digital Image Correlation System, Diagnostic Test: Weight-Bearing Ultrasound of the Plantar Fat PadParticipants with diabetes and a recently healed plantar forefoot (<3 months) of neuroischaemic aetiology, showing both sensory neuropathy and peripheral arterial disease. PAD is defined as a prior revascularisation procedure or by the absence of pedal pulses and monophasic or absent Doppler signal with an opening toe pressure ≤ 50 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with diabetes who have recently healed (<3 months) a diabetes-related foot ulcer.
Key inclusion criteria (5 listed)
- Age > 18 years
- Confirmed diabetes mellitus (type 1 or 2)
- Recently healed plantar DFU (forefoot, <3months)
- Able to walk 10m unaided
- Able to provide written consent
Key exclusion criteria (6 listed)
- Active ulceration or infection
- Hindfoot or non-plantar ulcer location
- Non-diabetic aetiology
- Previous ipsilateral minor amputation or contralateral major lower limb amputation
- Need for a walking aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedar™ In-Shoe Plantar Pressure Measurement SystemAlso: Pedar; Novel Pedar System; In-shoe pressure analysisThe Pedar™ system (Novel GmbH, Munich, Germany) is a validated in-shoe pressure mapping platform comprising thin flexible insoles embedded with capacitive sensors. It measures vertical plantar pressure distribution during walking. In this study, participants wear the insoles inside standardised footwear while walking 10 steps at a self-selected pace to quantify peak pressure and pressure-time integrals across defined foot regions. | Diagnostic test | Neuroischaemic Diabetes-related Foot Ulcer (DFU) Cohort, Neuropathic Diabetes-related Foot Ulcer (DFU) Cohort |
| STAMPS 3D Digital Image Correlation SystemAlso: STAMPS; Strain Analysis and Mapping of the Plantar Surface; 3D DIC plantar shear measurementThe STAMPS (Strain Analysis and Mapping of the Plantar Surface) platform uses 3D Digital Image Correlation to quantify deformation of a plastically deformable speckled insole during walking. Participants wear a soft boot containing the STAMPS insole and walk approximately ten steps at normal speed. This technique captures both vertical and tangential (shear) strain, providing spatial maps of plantar shear during gait. | Diagnostic test | Neuroischaemic Diabetes-related Foot Ulcer (DFU) Cohort, Neuropathic Diabetes-related Foot Ulcer (DFU) Cohort |
| Weight-Bearing Ultrasound of the Plantar Fat PadAlso: Plantar ultrasound; Ultrasound fat-pad assessment; Weight-bearing plantar imagingHigh-frequency ultrasound is used to measure the thickness of the plantar fat pad under weight-bearing conditions. Participants stand barefoot on a transparent polymethyl methacrylate (Plexiglass) platform while the transducer is applied from beneath to obtain cross-sectional images of the forefoot at the level of each metatarsal head. The measurement provides structural information about plantar soft-tissue thickness as a proxy measure for plantar fat pad thickness. | Diagnostic test | Neuroischaemic Diabetes-related Foot Ulcer (DFU) Cohort, Neuropathic Diabetes-related Foot Ulcer (DFU) Cohort |
Primary outcome
Difference in mean peak plantar pressure and peak shear strain between neuropathic and neuroischaemic cohorts
Time frame: Baseline (single 90-minute assessment visit)
Quantitative comparison of plantar load between neuropathic and neuroischaemic diabetic foot ulcer groups. Mean peak plantar pressure (kPa) will be derived from in-shoe Pedar™ measurements, and mean peak plantar shear strain (SMag) will be obtained from 3D Digital Image Correlation (STAMPS) analysis. Data will be collected during a single walking trial at the study visit and expressed as regional and whole-foot means. The primary analysis will evaluate between-group differences in these parameters using linear regression to determine the effect of peripheral arterial disease on plantar loading.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 40219920Sairally F, Turnbull RP, Siddle HJ, Russell DA, Brockett C, Culmer PR. Development and evaluation of a novel 3D in-shoe plantar strain measurement system: STAMPS3D. Proc Inst Mech Eng H. 2025 May;239(5):472-484. doi: 10.1177/09544119251330738. Epub 2025 Apr 12.
- Background: PubMed 37662427Crossland SR, Siddle HJ, Brockett CL, Culmer P. Evaluating the use of a novel low-cost measurement insole to characterise plantar foot strain during gait loading regimes. Front Bioeng Biotechnol. 2023 Aug 17;11:1187710. doi: 10.3389/fbioe.2023.1187710. eCollection 2023.
- Background: PubMed 37353979Jones AD, Crossland SR, Nixon JE, Siddle HJ, Russell DA, Culmer PR. STrain Analysis and Mapping of the Plantar Surface (STAMPS): A novel technique of plantar load analysis during gait. Proc Inst Mech Eng H. 2023 Jul;237(7):841-854. doi: 10.1177/09544119231181797. Epub 2023 Jun 24.
- Background: PubMed 10587827Pitei DL, Lord M, Foster A, Wilson S, Watkins PJ, Edmonds ME. Plantar pressures are elevated in the neuroischemic and the neuropathic diabetic foot. Diabetes Care. 1999 Dec;22(12):1966-70. doi: 10.2337/diacare.22.12.1966.
- Individual participant dataSharing planned: Undecided. The decision regarding IPD sharing will be made after study completion in consultation with the University of Leeds (sponsor) and Leeds Teaching Hospitals NHS Trust. Anonymised datasets may be deposited in the University's Research Data Repository if deemed appropriate and compliant with data governance and participant consent provisions.
Related trials for Foot Ulcers, Diabetic
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Foot Ulcers, Diabetic and Plantar Foot Pressure, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 28 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in mean peak plantar pressure and peak shear strain between neuropathic and neuroischaemic cohorts (time frame: Baseline (single 90-minute assessment visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07901478, which also lists 4 linked publications.
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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.