Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy (LEEF-shoe)

March 18, 2026 updated by: University Medical Center Groningen

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9700
        • Recruiting
        • University Medical Center Groningen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEEF-shoe then standard orthopaedic shoe
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.
Device: LEEF-shoe

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

Device: standard orthopaedic shoe
The standard orthopaedic shoe, which is the care as usual solution in the Netherland. ISO 13485 certified and optimized individually.
Experimental: Standard orthopaedic shoe then LEEF-shoe
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.
Device: LEEF-shoe

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

Device: standard orthopaedic shoe
The standard orthopaedic shoe, which is the care as usual solution in the Netherland. ISO 13485 certified and optimized individually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measured during the handover of both shoes, before the wearing periods.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Shoe peak plantar pressure
Time Frame: measured after the two wearing time periods (totalling 8 weeks)
Measured with the Pedar-X measurement system
measured after the two wearing time periods (totalling 8 weeks)
Wearing time
Time Frame: collected during the three subsequent wearing periods of four weeks
wearing time (adherence) measured with a orthotimer in each shoe
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
The weight of both pair of orthopedic shoes.
measured during the handover of both shoes, before the wearing periods
Body mass
Time Frame: After enrollment, baseline
The weight of the participant.
After enrollment, baseline
Focus group
Time Frame: After completion of the total protocol, after 12 weaks of wearing the ortopedic shoes.
Semi-structured interview regarding acceptance.
After completion of the total protocol, after 12 weaks of wearing the ortopedic shoes.
Participant height
Time Frame: After enrollment, baseline
Height of the participant.
After enrollment, baseline
Participants foot length
Time Frame: After enrollment, baseline
the length of the feet of the participants.
After enrollment, baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-010296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be stored in a registry or be made available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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