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Trial registered on ANZCTR


Registration number
ACTRN12625000905460
Ethics application status
Approved
Date submitted
4/06/2025
Date registered
20/08/2025
Date last updated
20/08/2025
Date data sharing statement initially provided
20/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of personalised 3D printed metamaterial insoles on plantar pressures in healthy adults.
Scientific title
Evaluation of the effect of 3D printed functionally graded metamaterial insoles on plantar pressures in healthy adults: A within subjects cross over study.
Secondary ID [1] 314248 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12624001175561 is a linked study that is being conducted by one member of the research team in this study. This linked study is exploring the same insole manufacturing techniques in a different application, creating insoles for use in offloading devices that are used as part of the treatment for diabetes related foot ulcers.

Health condition
Health condition(s) or problem(s) studied:
Diabetes-related foot ulceration 337452 0
Peripheral neuropathy 337453 0
Condition category
Condition code
Metabolic and Endocrine 333826 333826 0 0
Diabetes
Neurological 333827 333827 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Current Australian and international guidelines recommend the use of medical-grade footwear and personalised insoles to prevent diabetes-related foot ulceration in individuals at risk, particularly those with foot deformities or pre-ulcerative lesions.

This study will evaluate whether functionally graded 3D printed insoles that have material stiffness personalised according plantar pressure measurements are as effective as the current standard of care in reducing plantar pressures. It will also examine if the design algorithms and input pressures used to manufacture these insole effect their ability to reduce plantar pressures when used with medical grade footwear.

This study therefore includes several arms and intends to evaluate the effect of data-driven insole design algorithms. As a cross-over study, each participant will experience each intervention and control arm.

Participants will be invited to attend two appointments. Each appointment is anticipated to take approximately 60 minutes.

At an initial appointment, following screening for inclusion/exclusion criteria, plantar pressures will be measured barefoot and when wearing the issued medical grade trial footwear. This plantar pressure data will be used to design insoles using automated algorithms. Specifically, the plantar pressure will be used to define the stiffness of the metamaterial across the insole.

This study has four intervention arms and three control arms- for each intervention arm, different algorithm parameters will be used to define the stiffness of the metamaterial insole.
Intervention arm 1 will be a 3D printed metamaterial insole comprising metamaterials of uniform stiffness that approximates low density EVA foam (the current standard of care). Intervention arms 2-4 will be a 3D printed metamaterial insoles comprising metamaterials with graded stiffness that ranges from low density EVA foam (at hardest) through to Poron a material commonly used as a component of insoles designed to reduce plantar pressures in clinical practice (at softest). The stiffness of the insole will be set based upon the peak plantar pressure at the corresponding part of the foot. Between these thresholds, the stiffness will be interpolated.

For intervention arm 2, The design algorithm parameters will define a broad transition zone., whereby at sites of the foot with low pressures (200kPa), the insole will have properties approximating Poron.

For intervention arm 3, The design algorithm parameters will define a moderate transition zone, whereby at sites of the foot with low pressures (200kPa), the insole will have properties approximating Poron.

For intervention arm 4, The design algorithm parameters will define a narrow transition zone., whereby at sites of the foot with low pressures (200kPa), the insole will have properties approximating Poron.

Prior engineering work has benchmarked the stiffness of the metamaterial to that of materials that are commonly used in insole and footwear manufacture (EVA faom and Poron).

Following the initial appointment, each of the interventions and control insoles will be designed and fabricated for the individual. The second appointment is anticipated to occur 2-4 weeks following the initial appointment.

At the second appointment, each of the intervention and control insoles will be fit to a the standardised medical grade footwear in a randomised order. The participant will be blinded to the difference between the different insole conditions. Primary outcome measures (plantar pressure in device during gait) will be recorded after a brief period of acclimatisation.(at least 2 minutes). The participant will walk straight for approximately 10m at a self-selected speed while data is recorded to provide at least 12 steps of data for the foot. Walking speed during the trial will be self selected for the first trial and measured, to ensure each subsequent trial is within ten percent of this speed. Trials outside of this will be discarded and repeated to ensure walking speed is kept consistent during testing of each condition. Three trials will be completed for each study arm. There will be an washout and rest period between study arms of at least 3 minutes.

As an immediate effects study design, insoles will not be worn for an extended period nor taken by the participants, and no assessment of adherence will be performed. Should any intervention be discontinued prior to data collection (e.g. due to discomfort reported by participant), this will be reported.

Each intervention insole will be designed, manufactured, and fit by a podiatrist at a university research facility.
Intervention code [1] 331044 0
Treatment: Devices
Comparator / control treatment
Three control arms will be used in this study:
Control Arm 1 (Reference comparator): standardised medical grade footwear - This represents footwear that meets current guidelines for use by people at risk of diabetes related foot ulceration with foot deformity and/or pre-ulcerative lesions.
Control Arm 2: Standardised medical grade footwear and current standard of care personalised insole fabricated using standard manufacture means (i.e. CNC milled Ethylene-Vinyl Acetate) to contour the plantar surface of the foot but without personalisation of mechanical properties of the insole i.e. with uniform stiffness. This represents a frequent current practice.
Control Arm 3: Barefoot - Many people at risk of diabetes related foot ulceration continue to walk barefoot.
Control group
Active

Outcomes
Primary outcome [1] 341431 0
Peak plantar pressure
Timepoint [1] 341431 0
Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition
Secondary outcome [1] 447488 0
Percentage area of foot where peak plantar pressures are reduced by 30% or more or to below 200kpa.
Timepoint [1] 447488 0
Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition.
Secondary outcome [2] 447490 0
Comfort in each insole condition
Timepoint [2] 447490 0
Immediately following trials for each insole condition.
Secondary outcome [3] 447491 0
Pressure-time integral.
Timepoint [3] 447491 0
Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition.
Secondary outcome [4] 447492 0
Spatiotemporal parameters of gait
Timepoint [4] 447492 0
This will be measured for each walking trial in each of the trial conditions.

Eligibility
Key inclusion criteria
Able to walk for 40 minutes without use of assistive devices (e.g. walking frame, walking stick).
Available to attend a follow up appointment 2-4 weeks after the initial appointment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Evidence of peripheral arterial disease.
Loss of peripheral protective sensation.
Current or history of previous foot ulceration, Charcot neuroarthropathy, previous amputation of foot (at any level).
Previous amputation to lower limb.
History of falls in previous 12 months.
Current or recent (4 weeks) self-reported foot or leg pain.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed - All participants will experience all intervention arms in this immediate-effects crossover trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which participants will trial each intervention orthosis will be randomised through computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVAs will be used to test the differences between intervention and control arms on plantar pressure outcomes with Bonferroni post-hoc testing used for multiple pairwise comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2025
Actual
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
23/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318768 0
Government body
Name [1] 318768 0
Australian Department of Health, Disability and Ageing, Medical Research Futures Fund (MRFF)
Country [1] 318768 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 321427 0
None
Name [1] 321427 0
Address [1] 321427 0
Country [1] 321427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317378 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 317378 0
Ethics committee country [1] 317378 0
Australia
Date submitted for ethics approval [1] 317378 0
19/03/2025
Approval date [1] 317378 0
12/05/2025
Ethics approval number [1] 317378 0
LR 2025-9421-24112

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140866 0
Prof Mia Woodruff
Address 140866 0
Biofabrication and Tissue Morphology Group, Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 140866 0
Australia
Phone 140866 0
+61 7 31387778
Fax 140866 0
Email 140866 0
[email protected]
Contact person for public queries
Name 140867 0
Katie Green
Address 140867 0
Biofabrication and Tissue Morphology Group, Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 140867 0
Australia
Phone 140867 0
+61 7 31380133
Fax 140867 0
Email 140867 0
[email protected]
Contact person for scientific queries
Name 140868 0
Katie Green
Address 140868 0
Biofabrication and Tissue Morphology Group, Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 140868 0
Australia
Phone 140868 0
+61 7 31380133
Fax 140868 0
Email 140868 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be made available on QUT's publicly accessible data repository.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Data will be made available on QUT's publically accessible data repository, via https://data.researchdatafinder.qut.edu.au.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.