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Clinical Trials/NL-OMON30851
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

Academisch Medisch Centrum0 sites240 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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