NL-OMON30851
Not yet recruiting
Not Applicable
The effectiveness of plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration in diabetic patients: a randomised controlled trial - DIAFOS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 240
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>18 and \<85 years old
- •2\. Diagnosis of diabetes mellitus Type 1 or 2
- •3\. Loss of protective sensation due to peripheral neuropathy
- •4\. A history of plantar foot ulceration within the last 18 months
- •5\. A new therapeutic footwear prescription (OSA or OSB)
Exclusion Criteria
- •1\. Active foot ulceration
- •2\. Amputation proximal to the metatarsal bones in the foot
- •3\. Severe illness that would make 18\-months survival unlikely
- •4\. The use of walking aids that contribute to offloading the foot (wheel chair, more than one crutch)
- •5\. Parallel participation in another study that may influence the outcomes of this study.
- •6\. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study.
Outcomes
Primary Outcomes
Not specified
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