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

Diabetic Foot Ulcer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039645
• Other study ID #: BMS CP001
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: January 2024
• Source: Bluedrop Medical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Behavioral:
• Patient specific, clinician determined Intervention
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).

Locations

Country	Name	City	State
Ireland	Merlin Park University Hospital	Galway
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Bluedrop Medical Limited

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

References & Publications (11)

Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N, Johnson KE, Ryder CH, Torkington R, Van Ross ER, Whalley AM, Widdows P, Williamson S, Boulton AJ; North-West Diabetes Foot Care Study. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med. 2002 May;19(5):377-84. doi: 10.1046/j.1464-5491.2002.00698.x. — View Citation

Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available. — View Citation

Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028. Erratum In: Am J Med. 2008 Dec;121(12). doi: 10.1016/j.amjmed.2008.09.029. — View Citation

Boulton AJ, Kirsner RS, Vileikyte L. Clinical practice. Neuropathic diabetic foot ulcers. N Engl J Med. 2004 Jul 1;351(1):48-55. doi: 10.1056/NEJMcp032966. No abstract available. — View Citation

Bus SA, van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE; International Working Group on the Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:16-24. doi: 10.1002/dmrr.2696. No abstract available. — View Citation

Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:195-200. doi: 10.1002/dmrr.2738. — View Citation

Jeffcoate WJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcers. Diabetes Care. 2018 Apr;41(4):645-652. doi: 10.2337/dc17-1836. — View Citation

Kerr M, Barron E, Chadwick P, Evans T, Kong WM, Rayman G, Sutton-Smith M, Todd G, Young B, Jeffcoate WJ. The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med. 2019 Aug;36(8):995-1002. doi: 10.1111/dme.13973. Epub 2019 Jun 5. — View Citation

Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642. — View Citation

Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;30(1):14-20. doi: 10.2337/dc06-1600. — View Citation

Yap MH, Chatwin KE, Ng CC, Abbott CA, Bowling FL, Rajbhandari S, Boulton AJM, Reeves ND. A New Mobile Application for Standardizing Diabetic Foot Images. J Diabetes Sci Technol. 2018 Jan;12(1):169-173. doi: 10.1177/1932296817713761. Epub 2017 Jun 21. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Adherence	Patient adherence, tracked throughout duration of study, as measured through the number of device uses in each week, and the average number of device uses over the whole study.	3 months
Secondary	Clinic reported utility of thermovisual data for remote analysis and remote intervention - Number of scans in each Likert response category	On receipt of a report due to an identified issue the clinic will be asked to complete a brief survey to determine utility of thermovisual data to remotely assess and issue guidance to the patient. The survey will use a 5-point Likert scale to assess overall usefulness of the report for (1) remote analysis and (2) remote intervention. Responses will be scored from 1 (Strongly Disagree) to 5 (Strongly Agree), where larger scores indicate a more positive experience with the device.; The number of scans in each Likert response category will be presented.	3 months
Secondary	Clinic reported utility of thermovisual data for remote analysis and remote intervention - Percentage of scans in each Likert response category	On receipt of a report due to an identified issue the clinic will be asked to complete a brief survey to determine utility of thermovisual data to remotely assess and issue guidance to the patient. The survey will use a 5-point Likert scale to assess overall usefulness of the report for (1) remote analysis and (2) remote intervention. Responses will be scored from 1 (Strongly Disagree) to 5 (Strongly Agree), where larger scores indicate a more positive experience with the device.; The percentage of scans in each Likert response category will be presented.	3 months
Secondary	Level of agreement between in-person visual assessment and remote assessment.	When the patient reports for a scheduled or unscheduled visit the clinic will carry out an in-person visual assessment of the feet. Visible signs of skin damage on the plantar surface of the feet will be recorded. In addition to this, at the end of the study, a blinded clinician will retrospectively review the 4 thermovisual scans taken prior to the schedule or unscheduled visit and record any signs of skin damage. The level of agreement between the in-person visual assessment and the remote assessment using the scans will then be determined.Identified skin issues in both the in-person and remote assessments will be categorized and grouped together using headings such as DFU, callus, discoloration, deformation. The location of the issue will also be recorded (e.g. plantar surface, interdigit, etc).; The degree of agreement between the dichotomous scores from in-person visual assessment and the remote scan assessment will be determined using Cohen's kappa (?).	3 months
Secondary	Patient reported device usability	Patient reported device convenience, ease of use, usefulness of text reminders, impact on attitude towards care and overall satisfaction will be assessed via a survey during, and at the end, of the study.	3 months
Secondary	DFU Incidence rates and severities	DFU severity will be assessed using the Texas wound classification system and the SINBAD scale. The relative depth of the ulcer, presence of infection or ischaemia or both will be used to categorise the wound grade and stage. The SINBAD Classification System assigns a SINBAD score from 0 to 6 to each ulcer based on a set of criteria, and larger scores indicate more severe ulcers.	3 months