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

Primary Purpose

Foot Ulcer, Diabetic

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermidas Vista Telehealth App
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

device feasibility

Arm Description

All participants issued with Thermidas device

Outcomes

Primary Outcome Measures

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
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
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
Device Feasibility - Safety
Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
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)
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
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.
Device Feasibility - Patient feedback on device use
Patient completion of User Questionnaire Form (Week 12) (target 80% completion)

Secondary Outcome Measures

Full Information

First Posted
August 22, 2023
Last Updated
September 11, 2023
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Robertson Centre for Biostatistics
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1. Study Identification

Unique Protocol Identification Number
NCT06032221
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Robertson Centre for Biostatistics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
device feasibility
Arm Type
Other
Arm Description
All participants issued with Thermidas device
Intervention Type
Device
Intervention Name(s)
Thermidas Vista Telehealth App
Intervention Description
Thermal camera with telemedicine app
Primary Outcome Measure Information:
Title
Device Feasibility - Completion
Description
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
Time Frame
12 weeks
Title
Device Feasibility - Withdrawal
Description
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
Time Frame
12 weeks
Title
Device Feasibility - Compliance
Description
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
Time Frame
12 weeks
Title
Device Feasibility - Safety
Description
Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
Time Frame
12 weeks
Title
Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
Description
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)
Time Frame
12 weeks
Title
Device Feasibility - Health Economics
Description
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
Time Frame
12 weeks
Title
Device Feasibility - Staff feedback on device use
Description
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.
Time Frame
12 weeks
Title
Device Feasibility - Patient feedback on device use
Description
Patient completion of User Questionnaire Form (Week 12) (target 80% completion)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Kennon
Phone
0141 201 1100
Email
brian.kennon@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Ela Fergusson
Phone
0141 451 6869
Email
pamela.fergusson3@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Gillian Harkin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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