Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05236660
Eligibility Criteria:
Inclusion Criteria:
* Diabetes mellitus type 1 or 2
* Age 18 years or above
* Loss of protective sensation based on the presence of peripheral neuropathy
* A healed plantar foot ulcer or foot amputation in the preceding 4 years until two weeks before study inclusion
* In possession of custom-made orthopaedic shoes, defined as "Orthopaedic shoes type A" or "Orthopaedic shoes type B" , or Orthopaedic Provision in Regular Footwear (OVAC), according to the Dutch healthcare system
* Ability to provide informed consent
Exclusion Criteria:
* Foot ulcer or open amputation site(s)
* Active Charcot's neuroarthropathy
* Foot infection, based on criteria of the PEDIS classification
* Amputation proximal to the metatarsal bones in both feet
* Healed ulcer on the apex of digitus 2-5 as the only ulcer location in the past 4 years, as surgical intervention (flexor tenotomy) is a more likely and guideline-recommended treatment for such patients, rather than the multimodal care under investigation
* Severe illness that would make 12-months survival unlikely, based on the clinical judgment by the physician
* Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on clinical judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05236660
Study Brief:
Protocol Section:
NCT05236660