LEEF shoe for reducing plantar pressure and improving acceptance in people with diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.