Diabetic Foot UlcerNCT05039645
Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
A study testing Patient specific, clinician determined Intervention in people with Diabetic Foot Ulcer, run by Bluedrop Medical Limited at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Patient specific, clinician determined Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Mar 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Patient specific, clinician determined Intervention
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific, clinician determined InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Open Arm Study - All participants | Other | 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). Receives: Behavioral: Patient specific, clinician determined Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start31 Mar 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bluedrop Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Boulton, PhD, Principal investigator, Prof. of Medicine, University of Manchester & Consultant Physician, Manchester Royal InfirmaryCaroline McIntosh, PhD, Principal investigator, Podiatric Medicine School of Health Sciences Áras Moyola, NUI Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039645
- Sponsor's protocol ID
- BMS CP001
- Status last verified
- Jan 2024
- First submitted
- 4 Jun 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15504999Lavery 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.
PubMed 17192326Armstrong 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.
PubMed 18060924Armstrong 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.
PubMed 28614678Abbott 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.
PubMed 12027925Boulton 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.
PubMed 15229307Kerr 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.
PubMed 31004370Bus 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.
PubMed 26334001Bus 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.
PubMed 26452160Jeffcoate 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.
PubMed 29559450Yap 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.
PubMed 28637356
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05039645
- Acronym / sponsor ID
- BMS CP001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bluedrop Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open Arm Study - All participants | Other | Behavioral: Patient specific, clinician determined InterventionStudy 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient specific, clinician determined InterventionData 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). | Behavioural | Open Arm Study - All participants |
Primary outcome
Patient Adherence
Time frame: 3 months
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.
5 secondary outcomes
Clinic reported utility of thermovisual data for remote analysis and remote intervention - Number of scans in each Likert response category
Time frame: 3 months
Clinic reported utility of thermovisual data for remote analysis and remote intervention - Percentage of scans in each Likert response category
Time frame: 3 months
Level of agreement between in-person visual assessment and remote assessment.
Time frame: 3 months
Patient reported device usability
Time frame: 3 months
DFU Incidence rates and severities
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 15504999Lavery 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.
- Background: PubMed 17192326Lavery 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.
- Background: PubMed 18060924Armstrong 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.
- Background: PubMed 28614678Armstrong 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.
- Background: PubMed 12027925Abbott 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.
- Background: PubMed 15229307Boulton 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.
- Background: PubMed 31004370Kerr 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.
- Background: PubMed 26334001Bus 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.
- Background: PubMed 26452160Bus 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.
- Background: PubMed 29559450Jeffcoate 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.
- Background: PubMed 28637356Yap 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Boulton, PhD principal investigator
Prof. of Medicine, University of Manchester & Consultant Physician, Manchester Royal Infirmary
Caroline McIntosh, PhD principal investigator
Podiatric Medicine School of Health Sciences Áras Moyola, NUI Galway
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific, clinician determined Intervention in people with Diabetic Foot Ulcer, run by Bluedrop Medical Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05039645, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.