Stopped: Delays in device modifications. Unable to complete within MHRA timescale
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 problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this. Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks. If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.
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Device Feasibility - Completion
Timeframe: 12 weeks
Device Feasibility - Withdrawal
Timeframe: 12 weeks
Device Feasibility - Compliance
Timeframe: 12 weeks
Device Feasibility - Safety
Timeframe: 12 weeks
Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
Timeframe: 12 weeks
Device Feasibility - Health Economics
Timeframe: 12 weeks
Device Feasibility - Staff feedback on device use
Timeframe: 12 weeks
Device Feasibility - Patient feedback on device use
Timeframe: 12 weeks