An interventional study of OneStep Foot Scanner in Diabetic Foot Ulcer (DFU), sponsored by Bluedrop Medical Limited. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Bluedrop Medical Limited · Not applicable, Interventional, and Screening
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Bluedrop Medical Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months
Device: OneStep Foot Scanner
Patients with a history of previous DFU(s) will be matched with participants in the active arm and analyzed
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
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.
Time frame: 12 months
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
Time frame: 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.
Time frame: 12 months
Number of Patients who Experience Amputation Free Survival
Amputation free survival in a high-risk population of patients with recently healed DFUs
Time frame: 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
Time frame: 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
Time frame: 12 months
PROM
Survey-ascertained participant reported quality of life measures using the NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire using a Likert scale of 1 to 5 for frequency of symptoms where 1 represents "never" and 5 represents "all the time" - with higher scores signifying a poorer quality of life.
Time frame: 12 months
Resource utilization costs
Costs associated with ulcer and amputation care in a high-risk population of patients with recently healed DFUs
Time frame: 12 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bluedrop Medical Limited