Effects of individually optimized rocker midsoles and self-adjusting insoles on plantar pressure in persons with diabetes mellitus and loss of protective sensation.
A Malki, M Baltasar Badaya, R Dekker...
https://pubmed.ncbi.nlm.nih.gov/38154536Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07488104
Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
Led by University Medical Center Groningen · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
A
Amsterdam UMC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the LEEF-shoe with standard orthopedic shoes in adults with diabetes mellitus and peripheral neuropathy who are at increased risk for foot ulcers. The study focuses on whether the LEEF-shoe differs from standard shoes in how it distributes pressure on the foot, which is important as foot ulcers can lead to serious complications like amputation. The trial also looks at how long participants wear each shoe and how much they accept and like the footwear. Participants will receive two pairs of orthopedic shoes: the standard shoe and the LEEF-shoe, both provided through usual care. They will wear each shoe type for four weeks in a randomized order while their wearing time is continuously monitored. After eight weeks, pressure measurements are repeated and participants can choose which shoe to wear for an additional four weeks, during which wearing time continues to be recorded. The LEEF-shoe uses a standardized protocol to set the shoe's rocker design to potentially improve comfort and pressure relief compared to conventional shoes. During the study, researchers will measure peak plantar pressure at several points, wearing time, shoe and body measurements, and gather feedback through focus group sessions on user experience and acceptance. Participants will attend appointments for shoe fitting, pressure measurement, and follow-up visits. The study lasts a total of 12 weeks, including the free-choice period, and aims to ensure safety by comparing the new shoe type to standard care footwear.
CONDITIONS
Brief Title
Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with type 1 or type 2 diabetes mellitus
- Classified as IWGDF Risk 2 or 3
- Prescribed fully custom-made orthopedic footwear (OS type A)
- Able to provide informed consent
You will not qualify if you...
- Severe foot deformities
- Active Charcot's neuroarthropathy
- Having a foot ulcer or open amputation site
- Severe illness as judged by the physician
- Unable to walk at least 10 meters without interruption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants wear the LEEF-shoe and the standard orthopaedic shoe in a crossover design to compare plantar pressure and acceptance. The wearing periods consist of four weeks wearing the LEEF-shoe, followed by four weeks wearing the standard orthopaedic shoe, with shoe handovers before each period.
2 visits for shoe handovers (in-person)
Follow-up
Duration - 4 weeks
Participants have a four-week period of free shoe choice after completing the wearing periods, concluding with a focus group discussion to assess shoe acceptance.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9700
Actively Recruiting
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Research Team
J
Jelmer Braaksma, PhD
J
Juha M Hijmans, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
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.
Stein H Exterkate, Manon Jongebloed-Westra, Peter M Ten Klooster...
https://pubmed.ncbi.nlm.nih.gov/37705016Diabetic Foot Ulcers and Their Recurrence.
David G Armstrong, Andrew J M Boulton, Sicco A Bus
https://pubmed.ncbi.nlm.nih.gov/28614678