Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05039645
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2021-06-04
Brief Title:
Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
Sponsor:
Bluedrop Medical Limited
Organization:
Bluedrop Medical Limited
Study Overview
Official Title:
A Pilot Study to Investigate the Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer During the COVID-19 Pandemic
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the clinical trial is to investigate adherence to and effects of the Bluedrop Monitoring System BMS in high-risk patients with at least one previous diabetic foot ulcer DFU
The BMS is a remote thermovisual monitoring system which allows the condition of the soles of the feet to be remotely monitored for thermal and visual signs of inflammation both of which may signal the onset of certain conditions such as diabetic foot ulcers
It is comprised of the Delta Foot Scanner DFS device and its accompanying Sentinel Review Interface SRI software
The Covid-19 pandemic has driven the need for remote patient care where possible Although this is challenging for people with foot ulcers prevention is the key Remote thermovisual monitoring might help reduce recurrent foot ulcers and therefore the number of necessary hospital visits which always puts the patient at increased risk of Covid infection
The BMS is a remote thermovisual monitoring system which allows the condition of the soles of the feet to be remotely monitored for thermal and visual signs of inflammation both of which may signal the onset of certain conditions such as diabetic foot ulcers
It is comprised of the Delta Foot Scanner DFS device and its accompanying Sentinel Review Interface SRI software
The Covid-19 pandemic has driven the need for remote patient care where possible Although this is challenging for people with foot ulcers prevention is the key Remote thermovisual monitoring might help reduce recurrent foot ulcers and therefore the number of necessary hospital visits which always puts the patient at increased risk of Covid infection
Detailed Description:
Despite the introduction of preventative foot care guidelines DFUs have a high re-ulceration rate In the first 12 months following healing 30-50 will develop a subsequent DFU and by year 5 this rate increases to 70 Temperature monitoring has been proposed as a way to reduce this re-ulceration rate but has not been widely adopted
Based on the existing evidence groups such as the International Working Group on the Diabetic Foot IWGDF have recommended temperature monitoring for the prevention of recurrent foot ulcers
Despite these recommendations the technique has not been widely adopted This is likely due to a number of factors but NICE in their guidance document for the prevention and management of foot ulcers NG19 states
While temperature foot monitoring was found to be the only effective form of augmented self-examination the intervention tool was felt to be quite difficult to use and required a strongly motivated population to actually perform consistently and fill out the required log books
Bluedrop Medical have developed a product which leverages the existing evidence on temperature monitoring but builds it into a device which also includes the ability to take photographic images is easy to use and can integrate well with the healthcare system
The goal of the clinical trial is to demonstrate that patients will use the device consistently over the course of the study It will also be used to determine the clinician reported utility of thermovisual data to conduct a remote assessment or remote intervention
Based on the existing evidence groups such as the International Working Group on the Diabetic Foot IWGDF have recommended temperature monitoring for the prevention of recurrent foot ulcers
Despite these recommendations the technique has not been widely adopted This is likely due to a number of factors but NICE in their guidance document for the prevention and management of foot ulcers NG19 states
While temperature foot monitoring was found to be the only effective form of augmented self-examination the intervention tool was felt to be quite difficult to use and required a strongly motivated population to actually perform consistently and fill out the required log books
Bluedrop Medical have developed a product which leverages the existing evidence on temperature monitoring but builds it into a device which also includes the ability to take photographic images is easy to use and can integrate well with the healthcare system
The goal of the clinical trial is to demonstrate that patients will use the device consistently over the course of the study It will also be used to determine the clinician reported utility of thermovisual data to conduct a remote assessment or remote intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None