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Clinical Trials/ISRCTN72155978
ISRCTN72155978
Active, Not Recruiting
N/A

REAL PRETECTION - Preventing diabetic foot ulcers using real-time foot pressure monitoring and alert technologies

Manchester Metropolitan University0 sites90 target enrollmentApril 17, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Manchester Metropolitan University
Enrollment
90
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 17, 2023
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Diagnosis of diabetes
  • 2\. Diabetic peripheral neuropathy (VPT \=25 Volts and/or neuropathy disability score \=6\)
  • 3\. Capable of walking independently (30 steps, aids permitted)
  • 4\. Aged \>18 years
  • 5\. Able to understand all of the study requirements

Exclusion Criteria

  • 1\. Active/healed DFU within the last 3 months
  • 2\. Active Charcot neuroarthropathy
  • 3\. Absent pedal pulses
  • 4\. Limb/foot amputation (except toe amputations)
  • 5\. Cognitive impairment (Mini\-Mental State Examination \[Tombaugh \& MacIntyre, 1992])
  • 6\. Glomerular Filtration Rate (eGFR) \<30
  • 7\. NHS prescription footwear unsuitable for smart device use (as assessed by a podiatrist)

Outcomes

Primary Outcomes

Not specified

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