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

Launched by NHS GREATER GLASGOW AND CLYDE · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to monitor foot temperature at home for people with diabetes who are at high risk for developing foot ulcers. The study aims to see how acceptable and easy it is for patients to use a special infrared camera and smartphone to take daily pictures of their feet. By doing this, researchers hope to identify any potential issues before moving on to a larger study. If the temperature in the images is higher than normal, participants will be invited for a follow-up appointment to receive foot care advice and treatment if needed.

To participate in this study, individuals must be at least 18 years old, have diabetes (Type 1 or Type 2), and be able to walk independently. They also need to be considered at high risk for foot problems. However, people with active foot ulcers, infections, or certain severe health conditions are not eligible. Participants will be involved for 12 weeks, and their experience with the device will be evaluated through questionnaires at the beginning and end of the study to see how it impacts their quality of life and ease of use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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