Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer

BlueDop Medical

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: Patient specific, clinician determined Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039645

BMS CP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of diabetes mellitus types 1 or 2
2. Aged 18 years or older
3. Have loss of protective sensation based on the presence of peripheral neuropathy (Vibration Perception Threshold (VPT) ≥ 25V on either foot)
4. Have a recent history of a DFU (i.e. an ulcer, defined as cutaneous erosion through the dermis on the foot) which was present for at least 2 weeks and has healed within 2-18 months before entry into the study
5. Ability to provide informed consent
6. Able to walk independently for 10m or more
7. The patient has foot care from a podiatrist or is willing to undergo foot care by a podiatrist
8. Access to a mobile phone so able to receive text notifications, or access to a landline to receive telephone call notifications.

Exclusion criteria

1. Active foot ulceration or open amputation sites
2. An ulcer that has deemed to have healed within the 2 months prior to entry into the study
3. Weight, when fully clothed, of greater than 150kg.
4. Active Charcot neuro-osteoarthropathy
5. Active foot infection
6. Any history of lower limb amputation
7. Significant Peripheral Arterial Disease (PAD) defined as history of revascularisation or absence of foot pulses
8. Concomitant severe physical or mental condition(s) that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to use DFS, without having a carer who can perform the temperature measurements

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Open Arm Study - All participants

Other group

Description:

Study is open arm with no blinding or randomisation. Patients will receive standard care including frequent clinical visits, education, and preventative foot care/podiatry as required. Patients will also be given a DFS thermovisual scanner device. Patients will be instructed to use the DFS on a daily basis, at home, to record thermovisual data about the soles of their feet. Data collected from the DFS device will be transmitted to a remote, cloud-based server for daily review using the SRI software. If a temperature difference of \>2.2°C between similar points on the left and right feet is identified for 2 consecutive scans, or visible signs of skin damage are observed, the site will be notified and sent a report containing the findings. Once notified the site will contact the patient by telephone and determine the best course of action based on standard practices (e.g. offloading, attending an appointment).

Treatment:

Behavioral: Patient specific, clinician determined Intervention