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

Primary Purpose

Diabetic Foot Ulcer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Patient specific, clinician determined Intervention
Sponsored by
Bluedrop Medical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Merlin Park University Hospital
  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Arm Study - All participants

Arm 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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 (κ).
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.
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.

Full Information

First Posted
June 4, 2021
Last Updated
September 25, 2023
Sponsor
Bluedrop Medical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05039645
Brief Title
Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bluedrop Medical Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is a single-arm, open-label, multicentre, pilot/feasibility study evaluating the adherence and usability of daily use of remote thermovisual monitoring alongside standard of care in patients with a previous DFU.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Arm Study - All participants
Arm Type
Other
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Patient specific, clinician determined Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patient Adherence
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinic reported utility of thermovisual data for remote analysis and remote intervention - Number of scans in each Likert response category
Description
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.
Time Frame
3 months
Title
Clinic reported utility of thermovisual data for remote analysis and remote intervention - Percentage of scans in each Likert response category
Description
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.
Time Frame
3 months
Title
Level of agreement between in-person visual assessment and remote assessment.
Description
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 (κ).
Time Frame
3 months
Title
Patient reported device usability
Description
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.
Time Frame
3 months
Title
DFU Incidence rates and severities
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of diabetes mellitus types 1 or 2 Aged 18 years or older Have loss of protective sensation based on the presence of peripheral neuropathy (Vibration Perception Threshold (VPT) ≥ 25V on either foot) 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 Ability to provide informed consent Able to walk independently for 10m or more The patient has foot care from a podiatrist or is willing to undergo foot care by a podiatrist Access to a mobile phone so able to receive text notifications, or access to a landline to receive telephone call notifications. Exclusion Criteria: Active foot ulceration or open amputation sites An ulcer that has deemed to have healed within the 2 months prior to entry into the study Weight, when fully clothed, of greater than 150kg. Active Charcot neuro-osteoarthropathy Active foot infection Any history of lower limb amputation Significant Peripheral Arterial Disease (PAD) defined as history of revascularisation or absence of foot pulses 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Boulton, PhD
Organizational Affiliation
Prof. of Medicine, University of Manchester & Consultant Physician, Manchester Royal Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline McIntosh, PhD
Organizational Affiliation
Podiatric Medicine School of Health Sciences Áras Moyola, NUI Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merlin Park University Hospital
City
Galway
Country
Ireland
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15504999
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.
Results Reference
background
PubMed Identifier
17192326
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.
Results Reference
background
PubMed Identifier
18060924
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.
Results Reference
background
PubMed Identifier
28614678
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.
Results Reference
background
PubMed Identifier
12027925
Citation
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.
Results Reference
background
PubMed Identifier
15229307
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.
Results Reference
background
PubMed Identifier
31004370
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.
Results Reference
background
PubMed Identifier
26334001
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.
Results Reference
background
PubMed Identifier
26452160
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.
Results Reference
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PubMed Identifier
29559450
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.
Results Reference
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PubMed Identifier
28637356
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.
Results Reference
background

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

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