NL-OMON52177
Recruiting
Not Applicable
An integrated personalised assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST) - Personalised assistive devices approach for diabetic foot ulcer prevention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 'diabetic foot' 'foot ulcers'
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 126
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diabetes mellitus type 1 or 2
- •2\. Age 18 years or above
- •3\. Loss of protective sensation based on the presence of peripheral neuropathy
- •4\. A healed plantar foot ulcer or foot amputation in the preceding 4 years
- •until two weeks before study inclusion
- •5\. 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
- •6\. Ability to provide informed consent
Exclusion Criteria
- •1\. Foot ulcer or open amputation site(s)
- •2\. Active Charcot\*s neuroarthropathy
- •3\. Foot infection, based on criteria of the PEDIS classification
- •4\. Amputation proximal to the metatarsal bones in both feet
- •5\. 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
- •6\. Severe illness that would make 12\-months survival unlikely, based on the
- •clinical judgment by the physician
Outcomes
Primary Outcomes
Not specified
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