Diabetic Foot Ulcer (DFU)NCT06782386
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
A study testing OneStep Foot Scanner in people with Diabetic Foot Ulcer (DFU), run by Bluedrop Medical Limited at 2 sites in United States.
Trial summary
This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- OneStep Foot Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female patients 18 years or older
- Diagnosis of type 1 or type 2 diabetes mellitus
- History of a plantar DFU within 5 years of enrollment.
- Access to a phone on which they can receive study communications.
- SUBGROUP: a patient with an active Wagner grade 1 DFU may be enrolled if in the opinion of the investigator the wound is sufficiently epithelialized and can withstand the pressure applied during scanning.
Who cannot join
- Weight, when fully clothed, of greater than 300 kg (~330 lbs) NOTE: for participants over 150kg the device will need to be used from a seated position
- Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
- Active foot infection or gangrene
- Critical limb threatening ischemia as evidenced by rest pain, or the presence of gangrene on any part of the foot.
- Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, rule the patient is unreliable as a study participant
- Any travel plans expected to result in an interruption of device use for greater than 30 consecutive days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
Three Rivers Wound and Hyperbaric Center
North Port, Florida, 34289
About this study
Official title: A Prospective Observational Study Evaluating the Effectiveness of Photographic and Thermal Monitoring in the Management of High-risk Diabetic Foot Patients
This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database.
Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies.
Read more
Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months.
Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.
Read the detailed description
This study is a prospective, multicenter, observational investigation designed to assess the utility of Remote ThermoVisual Monitoring (RTVM) using the OneStep Foot Scanner™ in detecting diabetic foot ulcers (DFUs) at an earlier stage in high-risk populations. DFUs represent a significant clinical and economic burden, often leading to severe complications, including infections and amputations. Early detection and intervention are critical to reducing morbidity and improving patient outcomes.
The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation in participants using RTVM to a matched historical control group. The secondary objectives include ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints include assessing neuropathy-specific quality of life and evaluating the economic impact of RTVM on DFU and amputation care costs.
The study will enroll approximately 100 participants aged 18 years or older with a confirmed diagnosis of type 1 or type 2 diabetes mellitus and a history of plantar DFUs that have healed within the past five years. Eligible participants will be recruited across up to 30 SerenaGroup® clinical sites. Participants will use the OneStep Foot Scanner™ daily to capture thermographic and visual data of the soles of their feet, which will be analyzed to identify signs of inflammation, potential ulceration, or other abnormalities. The data collected will be reviewed periodically by healthcare professionals for signs requiring intervention.
Participants will be followed for a period of 12 months, during which they will undergo regular clinical evaluations and remote monitoring assessments. The study will not only evaluate the effectiveness of RTVM in reducing the severity of DFUs but also explore its impact on healthcare costs, quality of life, and overall disease management strategies.
This study aims to provide critical insights into the feasibility of implementing RTVM as a preventive tool in routine diabetic foot care and its potential role in mitigating the global burden of DFUs.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- OneStep Foot Scanner
- Keywords
- DFU, Remote monitoring, Thermovisual monitoring
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneStep Foot ScannerDevice
Daily scans with the OneStep Foot scanner will provide thermal and visual data of the soles of the feet to assist in early identification of risk factors associated with Diabetic Foot Ulcers
| Study group | Role | What they receive |
|---|---|---|
| Use of device | Active comparator | This cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months Receives: Device: OneStep Foot Scanner |
| Control Group from Retrospective Patient Database | No intervention | Patients with a history of previous DFU(s) will be matched with participants in the active arm and analyzed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of more severe DFUs presenting
Incidence of Wagner grade 2 or higher ulcer at the time of first presentation for patients with a history of DFUs that healed in the previous 5 years.
Measured: 12 months
Secondary outcomes (5)
Length of time to DFU development
Time to first evaluation in patients with new DFUs in a high-risk population of patients with healed (within 5 years) DFUs
Measured: 12 months
Number of Patients who Experience Ulcer Free Survival
Ulcer free survival (of Wagner Grade 2 or higher ulcers), in a high-risk population of patients with recently healed DFUs.
Measured: 12 months
Number of Patients who Experience Amputation Free Survival
Amputation free survival in a high-risk population of patients with recently healed DFUs
Measured: 12 months
Resource utilization
Incidence of inpatient admissions, emergency room visits and outpatient provider encounters in patients with new DFUs in a high-risk population of patients with recently healed DFUs
Measured: 12 months
Compliance with Recommended Device Use as Measured by Scan Data Collected from the Bluedrop OneStep Foot Scanner
Adherence with RTVM in participants assigned to use RTVM
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start5 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bluedrop Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, Principal investigator, Serena Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782386
- Sponsor's protocol ID
- BMS CP003
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating the Effectiveness of Photographic and Thermal Monitoring in the Management of High-risk Diabetic Foot Patients
- ClinicalTrials.gov ID
- NCT06782386
- Acronym / sponsor ID
- BMS CP003
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- DFU, Remote monitoring, Thermovisual monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bluedrop Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jan 2025 (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.
This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database.
Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies.
Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months.
Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.
Detailed description
This study is a prospective, multicenter, observational investigation designed to assess the utility of Remote ThermoVisual Monitoring (RTVM) using the OneStep Foot Scanner™ in detecting diabetic foot ulcers (DFUs) at an earlier stage in high-risk populations. DFUs represent a significant clinical and economic burden, often leading to severe complications, including infections and amputations. Early detection and intervention are critical to reducing morbidity and improving patient outcomes.
The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation in participants using RTVM to a matched historical control group. The secondary objectives include ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints include assessing neuropathy-specific quality of life and evaluating the economic impact of RTVM on DFU and amputation care costs.
The study will enroll approximately 100 participants aged 18 years or older with a confirmed diagnosis of type 1 or type 2 diabetes mellitus and a history of plantar DFUs that have healed within the past five years. Eligible participants will be recruited across up to 30 SerenaGroup® clinical sites. Participants will use the OneStep Foot Scanner™ daily to capture thermographic and visual data of the soles of their feet, which will be analyzed to identify signs of inflammation, potential ulceration, or other abnormalities. The data collected will be reviewed periodically by healthcare professionals for signs requiring intervention.
Participants will be followed for a period of 12 months, during which they will undergo regular clinical evaluations and remote monitoring assessments. The study will not only evaluate the effectiveness of RTVM in reducing the severity of DFUs but also explore its impact on healthcare costs, quality of life, and overall disease management strategies.
This study aims to provide critical insights into the feasibility of implementing RTVM as a preventive tool in routine diabetic foot care and its potential role in mitigating the global burden of DFUs.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of device | Active comparator | Device: OneStep Foot ScannerThis cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months |
| Control Group from Retrospective Patient Database | No intervention | –Patients with a history of previous DFU(s) will be matched with participants in the active arm and analyzed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients 18 years or older
- Diagnosis of type 1 or type 2 diabetes mellitus
- History of a plantar DFU within 5 years of enrollment.
- Access to a phone on which they can receive study communications.
- SUBGROUP: a patient with an active Wagner grade 1 DFU may be enrolled if in the opinion of the investigator the wound is sufficiently epithelialized and can withstand the pressure applied during scanning.
Key exclusion criteria (6 listed)
- Weight, when fully clothed, of greater than 300 kg (~330 lbs) NOTE: for participants over 150kg the device will need to be used from a seated position
- Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
- Active foot infection or gangrene
- Critical limb threatening ischemia as evidenced by rest pain, or the presence of gangrene on any part of the foot.
- Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, rule the patient is unreliable as a study participant
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 |
|---|---|---|
| OneStep Foot ScannerDaily scans with the OneStep Foot scanner will provide thermal and visual data of the soles of the feet to assist in early identification of risk factors associated with Diabetic Foot Ulcers | Device | Use of device |
Primary outcome
Number of more severe DFUs presenting
Time frame: 12 months
Incidence of Wagner grade 2 or higher ulcer at the time of first presentation for patients with a history of DFUs that healed in the previous 5 years.
5 secondary outcomes
Length of time to DFU development
Time frame: 12 months
Number of Patients who Experience Ulcer Free Survival
Time frame: 12 months
Number of Patients who Experience Amputation Free Survival
Time frame: 12 months
Resource utilization
Time frame: 12 months
Compliance with Recommended Device Use as Measured by Scan Data Collected from the Bluedrop OneStep Foot Scanner
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
Thomas Serena principal investigator
Serena Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneStep Foot Scanner in people with Diabetic Foot Ulcer (DFU), run by Bluedrop Medical Limited at 2 sites 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of more severe DFUs presenting (time frame: 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 1 Oct 2026.