Status:
TERMINATED
Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
Robertson Centre for Biostatistics
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any...
Eligibility Criteria
Inclusion
- Written informed consent
- Male or Female \>/ = 18 years of age
- Diabetes Mellitus type 1 or 2 according to WHO criteria
- independently ambulatory
- deemed high risk/ in remission via SCI diabetes foot risk stratification tool
- expected to comply with study schedule
Exclusion
- active foot ulcer or open amputation site
- active Charcot Neuro-osteoarthropathy
- active foot infection based on PEDIS classification criteria
- amputation proximal to the Chopart joint in one or both feet
- critical limb ischaemia (according to PEDIS classification)
- severe illness that would make 6-month survival unlikely based on the clinical judgement of the physician or podiatrist
- concomitant severe physical or mental conditions that limit the ability to follow the instructions of the study, based on the clinical judgement of the physician or podiatrist
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06032221
Start Date
July 14 2023
End Date
February 6 2025
Last Update
August 5 2025
Active Locations (1)
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1
Queen Elizabeth University Hospital
Glasgow, Glasgow, United Kingdom, G51 4TF