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NCT06782386 · ClinicalTrials.gov registry record · NA
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcer (DFU), sponsored by Bluedrop Medical Limited.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06782386 is a NA study of Diabetic Foot Ulcer (DFU) that is active but no longer recruiting, run by Bluedrop Medical Limited. The registered enrollment target is 100 participants, below the 510-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06782386, a NA study of Diabetic Foot Ulcer (DFU), is active but no longer recruiting, sponsored by Bluedrop Medical Limited.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Conditions Studied
Interventions
- DEVICE OneStep Foot Scanner
Study Locations (2)
Florida
- Three Rivers Wound and Hyperbaric Center - North Port
Pennsylvania
- SerenaGroup Monroeville - Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-02-05 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06782386
The ClinicalTrials.gov registry entry for NCT06782386 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 510-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (80% lower). The listed sponsor is Bluedrop Medical Limited, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 1 intervention - of which OneStep Foot Scanner is the first listed.
NCT06782386 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06782386 about?
NCT06782386 is a clinical study titled "Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers". 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 tim...
What is the current status of trial NCT06782386?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-02-05. Estimated completion is 2026-08.
What conditions does trial NCT06782386 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU).
What interventions are being tested in trial NCT06782386?
The interventions under investigation include: OneStep Foot Scanner (DEVICE).
Who is sponsoring clinical trial NCT06782386?
This trial is sponsored by Bluedrop Medical Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06782386 being conducted?
This trial has 2 study locations across Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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