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

July 31, 2025 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: device feasibility
All participants issued with Thermidas device
Device: Thermidas Vista Telehealth App
Thermal camera with telemedicine app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Feasibility - Completion
Time Frame: 12 weeks
Participants successful completion of 12 weeks (percentage of all subjects who were enrolled in the study with ≥70% considered successful target (21 patients). This will assess if usage of the device on a daily basis over a specific period of time is practical
12 weeks
Device Feasibility - Withdrawal
Time Frame: 12 weeks
Participants withdrawal (Percentage of all subjects who were enrolled in the study ≤30% considered successful target). A low withdrawal rate will demonstrate that usage of the device is practical over the time period
12 weeks
Device Feasibility - Compliance
Time Frame: 12 weeks
No submission of images - i.e. no image submissions for 7-consecutive days on 2-occasions, generating 2-alerts over 12 weeks (absolute number of 'no submission' alerts). A lack of compliance with the study protocol will demonstrate low feasibility for regular device usage
12 weeks
Device Feasibility - Safety
Time Frame: 12 weeks
Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
12 weeks
Device Feasibility - Health Economics
Time Frame: 12 weeks
Health care utilisation and costs. The podiatrists will keep a log of time spent checking images and additional appointments generated in response to alerts. Costs will be calculated using staff time x staff payment costs
12 weeks
Device Feasibility - Staff feedback on device use
Time Frame: 12 weeks
A focus group meeting with podiatrists will be scheduled at the end of the participant data collection period to obtain qualitative data relating to device use.
12 weeks
Device Feasibility - Patient feedback on device use
Time Frame: 12 weeks
Patient completion of User Questionnaire Form (Week 12) (target 80% completion)
12 weeks
Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
Time Frame: 12 weeks

Patient completion of EQ-5D-5L health utility score to obtain a health utility score at Baseline and at Week 12 (target 80% completion).

(The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), but each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Robertson Centre for Biostatistics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Actual)

February 6, 2025

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INGN21DI185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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