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

NHS Trust

Status: Terminated

Conditions: Foot Ulcer, Diabetic

Treatments: Device: Thermidas Vista Telehealth App

Study type: Interventional

Funder types: Other

Identifiers

NCT06032221

INGN21DI185

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

device feasibility

Other group

Description:

All participants issued with Thermidas device

Treatment:

Device: Thermidas Vista Telehealth App