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Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

NCT06782386 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-15

No results posted yet for this 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

  • Diabetic Foot Ulcer (DFU)

Interventions

DEVICE

OneStep Foot Scanner

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

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Bluedrop Medical Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Serena · Serena Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782386 on ClinicalTrials.gov