LEEF shoe for reducing plantar pressure and improving acceptance in people with diabetic neuropathy
Plantar Pressure and Acceptance of the LEEF-shoe in Individuals With Diabetes-related Neuropathy
This trial tests whether the LEEF shoe reduces pressure on the soles and is easier to wear for adults with diabetes-related neuropathy than standard custom orthopaedic shoes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT07488104 on ClinicalTrials.gov |
What this trial studies
Adults with type 1 or type 2 diabetes and moderate-to-high foot ulcer risk who have been prescribed fully custom-made orthopaedic footwear will be enrolled at University Medical Center Groningen. Participants will compare the LEEF-shoe—designed with a standardized rocker-setting protocol and a more appealing design—with their standard orthopaedic shoe. The primary outcome is plantar pressure distribution, with secondary outcomes of actual wearing time and user acceptance measured by objective monitoring and questionnaires. The trial tests whether a standardized, simpler prescription can provide comparable offloading while improving patient adherence.
Who should consider this trial
Good fit: Adults (18+) with type 1 or 2 diabetes at IWGDF risk level 2–3 who have been prescribed fully custom-made orthopaedic footwear and can walk at least 10 meters are ideal candidates.
Not a fit: People with severe foot deformities, active Charcot neuroarthropathy, a current foot ulcer or open amputation site, severe intercurrent illness, or inability to walk 10 meters are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the LEEF-shoe could provide comparable pressure relief with higher patient acceptance, potentially increasing wearing time and reducing ulcer risk.
How similar studies have performed: Prior work on rocker-soled and offloading footwear has demonstrated plantar pressure reductions, but the LEEF-shoe's standardized prescription protocol and patient-focused design are relatively new and not widely tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen, Provincie Groningen
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jelmer Braaksma, PhD
- Email: j.braaksma01@umcg.nl
- Phone: +31 6 24665798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.