Diabetic FootMASTERNCT06053047
Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
A study testing Bluedrop Monitoring Service (BMS) in people with Diabetic Foot, run by Bluedrop Medical Limited at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers. All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Bluedrop Monitoring Service (BMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to 18 Sep 2024
- 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
- Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing consent prior to any study-specific procedures.
- Male or female patients 18 years or older.
- Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit.
- History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening.
- Confirmation of presence of peripheral neuropathy with loss of protective sensation (documented in medical records or certain ICD-10 codes for care of patients with diabetes and loss of protective sensation)
- Patient has signed up for and provided or will provide consent to review of medical records available via the Pluto platform.
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- Access to internet service at the site of device use or willing to use a 4G router provided by the Sponsor
- Access to cell phone on which they can receive study communications
- Has a healthcare provider who is confirmed to be their point of contact for foot care or injuries and this HCP uses an EHR that is compatible with Pluto
- English speaking
Who cannot join
- Patients with active foot ulcers or other open foot lesions
- Weight, when fully clothed, of greater than 150 kg
- Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
- Active foot infection or gangrene
- Any history of major or minor lower limb amputation of more than 3 toes. NOTE: the hallux toe must be present on both feet to be eligible
- Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicates adequate perfusion and qualifies for the study
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- End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renal replacement therapy)
- Known pregnancy at the time of enrollment.*
- Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, the patient is unreliable as a study participant
- Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days.
- Unable to identify and/or return to a usual care provider for foot care for the duration of the study
- Unable or unwilling to be enrolled in the Pluto unified medical records system
- Other issue that, at the discretion of the PI, renders the participant ineligible for participation. This includes inability to use the BMS for at least 3 days per week.
- Participants who become pregnant during the study will not be removed. Pregnancy will be noted in their mobile application profile and their participation in the study will be closely monitored.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27701
About this study
Official title: Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs
The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.
All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months.
Participants selected to receive the Bluedrop Monitoring System (BMS) will place it in their home and stand on it once a day for 12 months. Participants will also need to answer questions about their general foot health and, if using the system, their experience using the device and monitoring service.
Read the detailed description
This is a siteless study, which is planned to enroll approximately 200 patients with diabetes mellitus and a foot ulcer which has healed within 2-24 months prior to screening. The study will be organized and conducted via a central coordinating center at the Duke Clinical Research Institute. Potentially eligible patients within the state of North Carolina will be contacted about the study and if willing, will provide consent to participation remotely, including use of the Pluto Health''s unified medical records platform. Participants will not attend study sites, as all study visits will take place virtually and/or by telephone contact from the coordinating center and the primary study outcomes will be ascertained by review of health records via the Pluto system.
All enrolled participants will be randomized to use of the Bluedrop Monitoring System (BMS) or not in addition to their otherwise usual care. Participants assigned to use of the Bluedrop Monitoring System (BMS) will be provided the Delta Foot Scanner device with monitoring system and will be instructed in daily device use by Bluedrop personnel.
Participants will continue to receive all other usual care during the study period, and the patient's other care may be adjusted as considered clinically appropriate by the usual care provider(s).
After study enrollment, study visits will take place at 3, 6, 9 and 12 months. These visits will include participant surveys including assessment of neuropathy-specific quality of life, and review of health records via the Pluto Health platform by the study Principal Investigator (PI) to identify the occurrence of foot injury or ulcer and any associated medical or surgical care.
- Conditions
- Diabetic Foot
- Being tested
- Bluedrop Monitoring Service (BMS)
- Keywords
- Diabetic Foot Ulcer (DFU), Remote monitoring, Telemedicine
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluedrop Monitoring Service (BMS)Device
Remote use of ThermoVisual monitoring
| Study group | Role | What they receive |
|---|---|---|
| Use of Bluedrop Monitoring Service | Experimental | The BMS is made up of the Delta Foot Scanner (DFS) device, its accompanying Sentinel Review Interface (SRI) software and a Bluedrop virtual monitoring service.
The DFS is intended to be used for 30 seconds, once per day, by a person in their home. It is important that while using the device that the participant continues with their routine foot care as recommended by their doctor. Receives: Device: Bluedrop Monitoring Service (BMS) |
| Standard of care | No intervention | Participants continue with routine foot care as recommended by their doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers where a higher score is a worse outcome <min score of 0 and max score of 3>) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
Measured: Up to 12 months
Secondary outcomes (3)
Participant engagement rates in the Bluedrop Monitoring System (BMS)
Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
Measured: Up to 12 months
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs)
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
Measured: Up to 12 months
Relative risk reduction in resource utilization
Both all-cause and related to diabetic foot complications, in participants assigned to use of the Bluedrop Monitoring System (BMS) compared to those not assigned to use of the Bluedrop Monitoring System (BMS)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start22 Jan 2024
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Why it stopped: Unsustainable recruitment rate - too slow to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bluedrop Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Green, MD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053047
- Sponsor's protocol ID
- BMS CP002
- Acronym
- MASTER
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs
- ClinicalTrials.gov ID
- NCT06053047
- Acronym / sponsor ID
- MASTER / BMS CP002
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot Ulcer (DFU), Remote monitoring, Telemedicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsustainable recruitment rate - too slow to enroll participants
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bluedrop Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 25 Sep 2023 (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 purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.
All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months.
Participants selected to receive the Bluedrop Monitoring System (BMS) will place it in their home and stand on it once a day for 12 months. Participants will also need to answer questions about their general foot health and, if using the system, their experience using the device and monitoring service.
Detailed description
This is a siteless study, which is planned to enroll approximately 200 patients with diabetes mellitus and a foot ulcer which has healed within 2-24 months prior to screening. The study will be organized and conducted via a central coordinating center at the Duke Clinical Research Institute. Potentially eligible patients within the state of North Carolina will be contacted about the study and if willing, will provide consent to participation remotely, including use of the Pluto Health''s unified medical records platform. Participants will not attend study sites, as all study visits will take place virtually and/or by telephone contact from the coordinating center and the primary study outcomes will be ascertained by review of health records via the Pluto system.
All enrolled participants will be randomized to use of the Bluedrop Monitoring System (BMS) or not in addition to their otherwise usual care. Participants assigned to use of the Bluedrop Monitoring System (BMS) will be provided the Delta Foot Scanner device with monitoring system and will be instructed in daily device use by Bluedrop personnel.
Participants will continue to receive all other usual care during the study period, and the patient's other care may be adjusted as considered clinically appropriate by the usual care provider(s).
After study enrollment, study visits will take place at 3, 6, 9 and 12 months. These visits will include participant surveys including assessment of neuropathy-specific quality of life, and review of health records via the Pluto Health platform by the study Principal Investigator (PI) to identify the occurrence of foot injury or ulcer and any associated medical or surgical care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of Bluedrop Monitoring Service | Experimental | Device: Bluedrop Monitoring Service (BMS)The BMS is made up of the Delta Foot Scanner (DFS) device, its accompanying Sentinel Review Interface (SRI) software and a Bluedrop virtual monitoring service. The DFS is intended to be used for 30 seconds, once per day, by a person in their home. It is important that while using the device that the participant continues with their routine foot care as recommended by their doctor. |
| Standard of care | No intervention | –Participants continue with routine foot care as recommended by their doctor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing consent prior to any study-specific procedures.
- Male or female patients 18 years or older.
- Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit.
- History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening.
- Confirmation of presence of peripheral neuropathy with loss of protective sensation (documented in medical records or certain ICD-10 codes for care of patients with diabetes and loss of protective sensation)
Key exclusion criteria (14 listed)
- Patients with active foot ulcers or other open foot lesions
- Weight, when fully clothed, of greater than 150 kg
- Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
- Active foot infection or gangrene
- Any history of major or minor lower limb amputation of more than 3 toes. NOTE: the hallux toe must be present on both feet to be eligible
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 |
|---|---|---|
| Bluedrop Monitoring Service (BMS)Remote use of ThermoVisual monitoring | Device | Use of Bluedrop Monitoring Service |
Primary outcome
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)
Time frame: Up to 12 months
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers where a higher score is a worse outcome <min score of 0 and max score of 3>) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
3 secondary outcomes
Participant engagement rates in the Bluedrop Monitoring System (BMS)
Time frame: Up to 12 months
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs)
Time frame: Up to 12 months
Relative risk reduction in resource utilization
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Unsustainable recruitment rate - too slow to enroll participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Jennifer Green, MD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bluedrop Monitoring Service (BMS) in people with Diabetic Foot, run by Bluedrop Medical Limited at 1 site in United States.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Unsustainable recruitment rate - too slow to enroll participants). Results are not available in the source record.
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?
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.