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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2025-02-06

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.

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Detailed Description

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Conditions

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Foot Ulcer, Diabetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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device feasibility

All participants issued with Thermidas device

Group Type OTHER

Thermidas Vista Telehealth App

Intervention Type DEVICE

Thermal camera with telemedicine app

Interventions

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Thermidas Vista Telehealth App

Thermal camera with telemedicine app

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes