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

NCT07488104 | Recruiting

• 1 other identifier: NL-010296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Diabetic Neuropathy

Keywords

orthopaedic footwear; Diabetes Mellitus; Diabetic foot; Wearing time; Plantar pressure

Outcome Measures

Primary Outcomes (1)

• In-shoe peak plantar pressure

  Measured with the Pedar-X measurement system

  measured during the handover of both shoes, before the wearing periods.

Secondary Outcomes (7)

• In-Shoe peak plantar pressure

  measured after the two wearing time periods (totalling 8 weeks)

• Wearing time

  collected during the three subsequent wearing periods of four weeks

• Shoe mass

  measured during the handover of both shoes, before the wearing periods

• Body mass

  After enrollment, baseline

• Focus group

  After completion of the total protocol, after 12 weaks of wearing the ortopedic shoes.

Study Arms (2)

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.

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.

Device: LEEF-shoe; Device: standard orthopaedic shoe

Interventions

LEEF-shoe DEVICE

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

LEEF-shoe then standard orthopaedic shoe; Standard orthopaedic shoe then LEEF-shoe

standard orthopaedic shoe DEVICE

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

LEEF-shoe then standard orthopaedic shoe; Standard orthopaedic shoe then LEEF-shoe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Amsterdam UMC: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 38154536 BACKGROUND

• Exterkate 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.

  PMID: 37705016 BACKGROUND

• Armstrong 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.

  PMID: 28614678 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jelmer Braaksma, PhD

CONTACT

+31 6 24665798; j.braaksma01@umcg.nl

Juha M Hijmans, PhD

CONTACT

+31 (0)6 55256225; j.m.hijmans@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)