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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: Thermidas Vista Telehealth App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: device feasibility<br>All participants issued with Thermidas device | Device: Thermidas Vista Telehealth App<br>* Thermal camera with telemedicine app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Feasibility - Completion | 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 | 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 | 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 | Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs) | 12 weeks | 
| Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument | 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 | 
| Device Feasibility - Health Economics | 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 | 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 | Patient completion of User Questionnaire Form (Week 12) (target 80% completion) | 12 weeks |