Clinical trial NCT06032221: Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Robertson Centre for Biostatistics
First posted: 2023-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The purpose of the study is to determine if the Thermidas camera with telemedicine app is a feasible device in the 2 patient cohorts (15 patients who have had previous diabetes foot ulceration and 15 patients who are deemed to be high risk of foot ulceration)
Primary purpose: DEVICE_FEASIBILITY

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 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.


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

Primary outcomes:
measure: Device Feasibility - Completion
timeFrame: 12 weeks
measure: Device Feasibility - Withdrawal
timeFrame: 12 weeks
measure: Device Feasibility - Compliance
timeFrame: 12 weeks
measure: Device Feasibility - Safety
timeFrame: 12 weeks
measure: Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
timeFrame: 12 weeks
measure: Device Feasibility - Health Economics
timeFrame: 12 weeks
measure: Device Feasibility - Staff feedback on device use
timeFrame: 12 weeks
measure: Device Feasibility - Patient feedback on device use
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
References: