Diabetic NeuropathyLEEF-shoeNCT07488104
Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
A study testing LEEF-shoe and standard orthopaedic shoe in people with Diabetic Neuropathy, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- LEEF-shoe and standard orthopaedic shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Aged 18 years or older
- Diabetes mellitus type 1 or 2
- IWGDF Risk 2 - 3
- Prescribed with fully custom-made orthopedic footwear (OS type A)
- Ability to provide informed consent
Who cannot join
- Severe foot deformities
- Active Charcot's neuroarthropathy
- Foot ulcer or open amputation site
- Severe illness, based on clinical judgment by the physician
- Not able to walk at least 10 meters uninterrupted
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9700
Jelmer M Braaksma, PhD, +31 (0)6 24665798, j.braaksma01@umcg.nl
About this study
Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS). However, the effectiveness of OS is highly dependent on the individual shoe technician's skill and experience, and OS is frequently perceived as unattractive by users.
To overcome these limitations, the LEEF-shoe was developed. It eliminates the need for a fully individualized shoe technician approach by using a standardized protocol to determine the rocker settings. This may provide comparable plantar pressure relief, while potentially improving patient acceptance due to its more appealing design and simplified prescription process.
Read more
Objective: The primary objective is to determine whether the LEEF-shoe differs from standard-OS in terms of plantar pressure distribution. Secondary objectives are evaluation of wearing time and user acceptance of both footwear types.
Study design: This study is a randomized cross-over trial. Participants will complete pre- and post-tests for plantar pressure distribution, wearing time will be measured, and focus group sessions will assess user experience and acceptance.
Study population: A total of 30 adults (≥18 years old) with diabetes mellitus and peripheral neuropathy, at increased risk for foot ulceration, will be included.
Intervention:
All participants will receive two pairs of OS, a standard-OS and an additional OS (e.g., the LEEF-shoe), both provided through usual care channels. At handover, plantar pressure measurements will be performed. Participants will then wear each shoe model for four weeks, one after the other, with wearing time continuously monitored. Following the 8-week period, participants return for a standard control appointment with the OS-technician, during which post-test pressure measurements are taken. Subsequently, participants are allowed to wear either shoe based on personal preference for an additional four weeks, during which wearing time continues to be recorded. The study concludes with focus group sessions to explore experiences and acceptance.
Main study parameters/endpoints:
The primary outcome of the study is peak plantar pressure. It will be compared between the standard-OS and LEEF-shoe during the randomization visit. The secondary outcomes are peak plantar pressures in 7 foot regions, wearing time of the OS and user experience and acceptance, assessed through semi-structured focus groups.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be screened for eligibility during their regular consultation with the prescribing physician and OS-technician. After inclusion, participants will follow standard care procedures, which include an initial shoe fitting, a midway fitting, the handover of both shoes, and two follow-up appointments. To minimize any potential risk associated with wearing the LEEF-shoe at home following the handover, it is required that the LEEF-shoe is at least equivalent to, or better than, the standard-OS in terms of function and safety. Since the LEEF-shoe is produced within the existing framework and standards of OS manufacturing, it is considered a variant of standard-OS and thus falls within the boundaries of standard care.
- Conditions
- Diabetic Neuropathy
- Being tested
- LEEF-shoe, standard orthopaedic shoe
- Keywords
- orthopaedic footwear, Diabetes Mellitus, Diabetic foot, Wearing time, Plantar pressure
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEEF-shoeDevice
The LEEF-shoe is a variant of a standard-OS and therefore follows identical classification. The LEEF-shoe is classified as custom-made medical devices under EU Medical Device Regulation (MDR), as they are prescribed in writing, designed with specific characteristics, and intended for the exclusive use of an individual patient. Consequently, they are exempt from CE-marking requirements. The processes at STEPP BV for these custom-made medical devices are ISO 13485 certified. This certification is also required for the production of medical devices. These processes are governed by Standard Operating Procedures (SOP), which describe how the process is to be carried out.
The LEEF-shoe utilizes a rocker algorithm (simple search) to optimize the shape. Both ways of producing OS (Standard-OS \& LEEF-shoe) fit in the SOPs of STEPP BV, following ISO 13485.
Standard-OS shoes typically consist of a supplement onto which the outsole is attached. The upper encloses the supplement. The suppleme
standard orthopaedic shoeDevice
The standard orthopaedic shoe, which is the care as usual solution in the Netherland. ISO 13485 certified and optimized individually.
| Study group | Role | What they receive |
|---|---|---|
| LEEF-shoe then standard orthopaedic shoe | Experimental | First four weeks wear of the LEEF-shoe, then four weeks wear of the standard orthopaedic shoe. Followed by four weeks of free shoe choice. Receives: Device: LEEF-shoe; Device: standard orthopaedic shoe |
| Standard orthopaedic shoe then LEEF-shoe | Experimental | First four weeks wear of the LEEF-shoe, then four weeks wear of the standard orthopaedic shoe. Followed by four weeks of free shoe choice. Receives: Device: LEEF-shoe; Device: standard orthopaedic shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-shoe peak plantar pressure
Measured with the Pedar-X measurement system
Measured: measured during the handover of both shoes, before the wearing periods.
Secondary outcomes (7)
In-Shoe peak plantar pressure
Measured with the Pedar-X measurement system
Measured: measured after the two wearing time periods (totalling 8 weeks)
Wearing time
wearing time (adherence) measured with a orthotimer in each shoe
Measured: collected during the three subsequent wearing periods of four weeks
Shoe mass
The weight of both pair of orthopedic shoes.
Measured: measured during the handover of both shoes, before the wearing periods
Body mass
The weight of the participant.
Measured: After enrollment, baseline
Focus group
Semi-structured interview regarding acceptance.
Measured: After completion of the total protocol, after 12 weaks of wearing the ortopedic shoes.
Participant height
Height of the participant.
Measured: After enrollment, baseline
Participants foot length
the length of the feet of the participants.
Measured: After enrollment, baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488104
- Sponsor's protocol ID
- NL-010296
- Acronym
- LEEF-shoe
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be stored in a registry or be made available upon reasonable request.
Publications
Malki A, Baltasar Badaya M, Dekker R, Verkerke GJ, Hijmans JM. Effects of individually optimized rocker midsoles and self-adjusting insoles on plantar pressure in persons with diabetes mellitus and loss of protective sensation. Diabetes Res Clin Pract. 2024 Jan;207:111077. doi: 10.1016/j.diabres.2023.111077. Epub 2023 Dec 26.
PubMed 38154536Exterkate SH, Jongebloed-Westra M, Ten Klooster PM, Koffijberg H, Bode C, van Gemert-Pijnen JEWC, van Baal JG, van Netten JJ. Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study. J Foot Ankle Res. 2023 Sep 14;16(1):60. doi: 10.1186/s13047-023-00656-6.
PubMed 37705016Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
PubMed 28614678
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
- ClinicalTrials.gov ID
- NCT07488104
- Acronym / sponsor ID
- LEEF-shoe / NL-010296
- Conditions
- Diabetic Neuropathy
- Keywords
- orthopaedic footwear, Diabetes Mellitus, Diabetic foot, Wearing time, Plantar pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam UMC
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Mar 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.
Rationale: Of all individuals with diabetes, 19-34% develop a foot ulcer in their lifetime, and nearly 25% of these ulcers result in amputation. Ulcer prevention is often addressed by prescribing orthopedic shoes (OS). However, the effectiveness of OS is highly dependent on the individual shoe technician's skill and experience, and OS is frequently perceived as unattractive by users.
To overcome these limitations, the LEEF-shoe was developed. It eliminates the need for a fully individualized shoe technician approach by using a standardized protocol to determine the rocker settings. This may provide comparable plantar pressure relief, while potentially improving patient acceptance due to its more appealing design and simplified prescription process.
Objective: The primary objective is to determine whether the LEEF-shoe differs from standard-OS in terms of plantar pressure distribution. Secondary objectives are evaluation of wearing time and user acceptance of both footwear types.
Study design: This study is a randomized cross-over trial. Participants will complete pre- and post-tests for plantar pressure distribution, wearing time will be measured, and focus group sessions will assess user experience and acceptance.
Study population: A total of 30 adults (≥18 years old) with diabetes mellitus and peripheral neuropathy, at increased risk for foot ulceration, will be included.
Intervention:
All participants will receive two pairs of OS, a standard-OS and an additional OS (e.g., the LEEF-shoe), both provided through usual care channels. At handover, plantar pressure measurements will be performed. Participants will then wear each shoe model for four weeks, one after the other, with wearing time continuously monitored. Following the 8-week period, participants return for a standard control appointment with the OS-technician, during which post-test pressure measurements are taken. Subsequently, participants are allowed to wear either shoe based on personal preference for an additional four weeks, during which wearing time continues to be recorded. The study concludes with focus group sessions to explore experiences and acceptance.
Main study parameters/endpoints:
The primary outcome of the study is peak plantar pressure. It will be compared between the standard-OS and LEEF-shoe during the randomization visit. The secondary outcomes are peak plantar pressures in 7 foot regions, wearing time of the OS and user experience and acceptance, assessed through semi-structured focus groups.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be screened for eligibility during their regular consultation with the prescribing physician and OS-technician. After inclusion, participants will follow standard care procedures, which include an initial shoe fitting, a midway fitting, the handover of both shoes, and two follow-up appointments. To minimize any potential risk associated with wearing the LEEF-shoe at home following the handover, it is required that the LEEF-shoe is at least equivalent to, or better than, the standard-OS in terms of function and safety. Since the LEEF-shoe is produced within the existing framework and standards of OS manufacturing, it is considered a variant of standard-OS and thus falls within the boundaries of standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEEF-shoe then standard orthopaedic shoe | Experimental | Device: LEEF-shoe, Device: standard orthopaedic shoeFirst four weeks wear of the LEEF-shoe, then four weeks wear of the standard orthopaedic shoe. Followed by four weeks of free shoe choice. |
| Standard orthopaedic shoe then LEEF-shoe | Experimental | Device: LEEF-shoe, Device: standard orthopaedic shoeFirst four weeks wear of the LEEF-shoe, then four weeks wear of the standard orthopaedic shoe. Followed by four weeks of free shoe choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Diabetes mellitus type 1 or 2
- IWGDF Risk 2 - 3
- Prescribed with fully custom-made orthopedic footwear (OS type A)
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Severe foot deformities
- Active Charcot's neuroarthropathy
- Foot ulcer or open amputation site
- Severe illness, based on clinical judgment by the physician
- Not able to walk at least 10 meters uninterrupted
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 |
|---|---|---|
| LEEF-shoeThe LEEF-shoe is a variant of a standard-OS and therefore follows identical classification. The LEEF-shoe is classified as custom-made medical devices under EU Medical Device Regulation (MDR), as they are prescribed in writing, designed with specific characteristics, and intended for the exclusive use of an individual patient. Consequently, they are exempt from CE-marking requirements. The processes at STEPP BV for these custom-made medical devices are ISO 13485 certified. This certification is also required for the production of medical devices. These processes are governed by Standard Operating Procedures (SOP), which describe how the process is to be carried out. The LEEF-shoe utilizes a rocker algorithm (simple search) to optimize the shape. Both ways of producing OS (Standard-OS \& LEEF-shoe) fit in the SOPs of STEPP BV, following ISO 13485. Standard-OS shoes typically consist of a supplement onto which the outsole is attached. The upper encloses the supplement. The suppleme | Device | LEEF-shoe then standard orthopaedic shoe, Standard orthopaedic shoe then LEEF-shoe |
| standard orthopaedic shoeThe standard orthopaedic shoe, which is the care as usual solution in the Netherland. ISO 13485 certified and optimized individually. | Device | LEEF-shoe then standard orthopaedic shoe, Standard orthopaedic shoe then LEEF-shoe |
Primary outcome
In-shoe peak plantar pressure
Time frame: measured during the handover of both shoes, before the wearing periods.
Measured with the Pedar-X measurement system
7 secondary outcomes
In-Shoe peak plantar pressure
Time frame: measured after the two wearing time periods (totalling 8 weeks)
Wearing time
Time frame: collected during the three subsequent wearing periods of four weeks
Shoe mass
Time frame: measured during the handover of both shoes, before the wearing periods
Body mass
Time frame: After enrollment, baseline
Focus group
Time frame: After completion of the total protocol, after 12 weaks of wearing the ortopedic shoes.
Participant height
Time frame: After enrollment, baseline
Participants foot length
Time frame: After enrollment, baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 38154536Malki A, Baltasar Badaya M, Dekker R, Verkerke GJ, Hijmans JM. Effects of individually optimized rocker midsoles and self-adjusting insoles on plantar pressure in persons with diabetes mellitus and loss of protective sensation. Diabetes Res Clin Pract. 2024 Jan;207:111077. doi: 10.1016/j.diabres.2023.111077. Epub 2023 Dec 26.
- Background: PubMed 37705016Exterkate SH, Jongebloed-Westra M, Ten Klooster PM, Koffijberg H, Bode C, van Gemert-Pijnen JEWC, van Baal JG, van Netten JJ. Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study. J Foot Ankle Res. 2023 Sep 14;16(1):60. doi: 10.1186/s13047-023-00656-6.
- Background: PubMed 28614678Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be stored in a registry or be made available upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEEF-shoe and standard orthopaedic shoe in people with Diabetic Neuropathy, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 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: looking for participants now, as of the sponsor's last update on 23 Mar 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jelmer Braaksma, PhD (+31 6 24665798, j.braaksma01@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-shoe peak plantar pressure (time frame: measured during the handover of both shoes, before the wearing periods.). 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 NCT07488104, which also lists 3 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 23 Mar 2026.