Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers

NCT06782386 | Active Not Recruiting FDA Device

• 1 other identifier: BMS CP003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

DFU; Remote monitoring; Thermovisual monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Length of time to DFU development

  12 months

• Number of Patients who Experience Ulcer Free Survival

  12 months

• Number of Patients who Experience Amputation Free Survival

  12 months

• Resource utilization

  12 months

• Compliance with Recommended Device Use as Measured by Scan Data Collected from the Bluedrop OneStep Foot Scanner

  12 months

Other Outcomes (2)

• PROM

  12 months

• Resource utilization costs

  12 months

Study Arms (2)

Use of device

ACTIVE COMPARATOR

This cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months

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

Interventions

OneStep Foot Scanner DEVICE

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

Use of device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bluedrop Medical Limited: lead
• Serena Group: collaborator

Study Sites (2)

Three Rivers Wound and Hyperbaric Center

North Port, Florida, 34289, United States

Location

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Thomas Serena

  Serena Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (2)