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

Overview

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.

Interventions

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

Primary outcome measures

• In-shoe peak plantar pressure [Time frame: measured during the handover of both shoes, before the wearing periods.]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Prevention

Study locations

Netherlands · 1 center

• University Medical Center Groningen — Groningen

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. PMID 38154536
• 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
• 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

Identifiers

NCT: NCT07488104 · NL-010296

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗