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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: Active NA study of Diabetic Foot Ulcer (DFU), sponsored by Bluedrop Medical Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the registry record for NCT06782386 still lists
NCT06782386 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 510-participant average among 13 other Diabetic Foot Ulcer (DFU) trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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
Similar trials for Diabetic Foot Ulcer (DFU)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06782386's enrollment target sits among peer trials
100 12th of 13 higher than 2 of 13 other Diabetic Foot Ulcer (DFU) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer (DFU) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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