Skip to main content
Clinical Trials/ISRCTN15738632
ISRCTN15738632
Active, not recruiting
未知

Diabetic foot ulcer prevention study using PelliTec pads

Sheffield Teaching Hospitals NHS Foundation Trust0 sites20 target enrollmentSeptember 24, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Diabetic foot ulcer
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Enrollment
20
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 24, 2021
End Date
October 17, 2023
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Age \>18 and less than 80 years old
  • 2\. Able and willing to give written informed consent
  • 3\. Diabetes (according to WHO criteria)
  • 4\. Distal symmetrical polyneuropathy confirmed by Michigan Neuropathy Screening Instrument (MNSI) score \>3 with Loss of Protective Sensation (LOPS) as defined by any loss of sensation as per MNSI assessments.
  • 5\. Healed plantar diabetic foot ulcer
  • 6\. Doppler ultrasound positive for at least one pedal pulse in each foot
  • 7\. Able to understand and willing to comply with all the study requirements
  • 8\. Be available for the duration of the study

Exclusion Criteria

  • 1\. Active diabetic foot ulcers
  • 2\. Non\-diabetic neuropathies
  • 3\. Active alcohol or substance abuse
  • 4\. Registered blind
  • 5\. Active/acute Charcot neuroarthropathy (chronic Charcot foot is not an exclusion criterion)

Outcomes

Primary Outcomes

Not specified

Similar Trials