NCT06032221

Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)

A Feasibility Study Assessing the Impact of At-home Infrared Temperature Monitoring (AITM) With Telemedicine Support in the Management of Patients With Potential for Diabetes Foot Ulceration

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	Thermidas Vista Telehealth App	Thermal camera with telemedicine app

Timeline

• Start date: 2023-07-14
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2023-09-11
• Last updated: 2025-08-05

Locations

1 site across 1 country: United Kingdom