Status:
COMPLETED
Personalised Assistive Devices Approach for Diabetic Foot Ulcer Prevention
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Preventing foot ulcers in people with diabetes can reduce costs and increase quality of life. Despite availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05236660
Start Date
March 2 2022
End Date
October 2 2025
Last Update
January 6 2026
Active Locations (5)
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1
Amsterdam UMC
Amsterdam, Netherlands
2
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
3
Reinier de Graaf Gasthuis
Delft, Netherlands
4
Spaarne Gasthuis
Hoofddorp, Netherlands