Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers (NCT06782386) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
United States100 participantsStarted 2025-02-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.