Not yet recruitingOBSERVATIONAL

FeetSee Thermal Images Collection Protocol in Diabetes Patients

This study is looking for adults with type 1 or type 2 diabetes who have had a foot ulcer in the past that has now healed, and also have nerve damage in their feet. It aims to test a new device called FeetSee, which is a special thermal camera that attaches to a smartphone or tablet. Participants will take daily pictures of their feet at home for 6-9 months. The camera looks for 'hot spots' on the feet that might mean inflammation, which could lead to a new foot ulcer. By collecting this information, researchers hope to improve how doctors prevent ulcers, which are a serious problem for people with diabetes. The study also checks how easy and safe the device is to use.

At a glance

Status

Not yet recruiting

Sponsor

Diabetis JSC

Enrolment target

100

Start

10 Dec 2025

Estimated completion

30 May 2027

Diabetic Foot Ulcer

What is this study about?

Imagine being able to spot a problem in your foot before it becomes a painful sore. That's what this study, called FeetSee, hopes to achieve. It's designed for people with diabetes because they can sometimes develop foot ulcers – open sores on the feet – without feeling any pain. This happens because high blood sugar can damage nerves, leading to 'diabetic peripheral neuropathy'. These ulcers can be very serious and sometimes even lead to losing a toe or part of a foot.

The study is testing a new device, a special thermal camera called FeetSee. Think of it like a camera that can 'see' heat. If a part of your foot is becoming inflamed, it might get warmer, creating a 'hot spot'. The FeetSee camera aims to spot these hot spots early. By finding these changes in temperature, doctors might be able to step in and prevent an ulcer from forming.

Researchers want to see if the FeetSee camera can reliably identify these warning signs in people who have had foot ulcers before. It will also help them improve the technology so it can be even better at predicting when new ulcers might develop. They'll also be checking how easy and safe the camera is for people to use in their everyday lives.

Key takeaways

The study uses a special camera (FeetSee) to look for warm spots on feet.
It's for people with diabetes who have had a foot ulcer and nerve damage.
Participants take daily foot pictures at home with a smartphone-connected camera.
The goal is to help prevent future foot ulcers by spotting early signs of inflammation.
You continue usual medical care while participating.

Who may be eligible?

This study is looking for adult men and women, aged 18 or older, who have either type 1 or type 2 diabetes. A key part of joining is that you must have had a diabetic foot ulcer in the past, and it needs to have been completely healed for at least six weeks before you start the study. You also need to have some nerve damage in your feet, which your doctor can check with simple tests, and at least one good pulse in your foot.

There are also some important reasons why you might not be able to join. For example, if you currently have an open foot ulcer, or a specific bone condition in your foot called Charcot neuro-osteoarthropathy, or very poor blood flow in your feet, you wouldn't be able to take part. Also, if you've had a major amputation of your lower leg or foot, or have other health issues that would make it difficult or unsafe for you to use the device, you couldn't be included.

Quick self-check

Are you an adult aged 18 or over?
Do you have type 1 or type 2 diabetes?
Have you had a plantar (bottom of the foot) diabetic foot ulcer that is now healed (for at least 6 weeks)?
Do you have nerve damage in your feet?
Do you have at least one normal pulse in your feet?
Do you *not* currently have an open foot ulcer or a serious foot bone condition called Charcot?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the FeetSee study, you'll first have a check-up where the study team will go over your medical history and test your feet for nerve damage. You'll then be given the FeetSee system, which includes a special thermal camera that connects to your own smartphone or tablet, a stand, and a mobile app. The study team will show you exactly how to use it.

Your main task will be to take thermal and regular pictures of both your feet at home, at least once every day. Before you take the pictures, you'll need to remove your shoes and socks and keep your feet still for about 10 minutes. These images will be sent securely to a cloud storage system for analysis. This will continue for 6 to 9 months, or until a new foot ulcer develops. You'll receive regular phone calls from the study staff every few weeks to check in and help with any issues. It's important to use the device regularly; if you don't use it for 21 days in a row, it's like leaving the study. Throughout the study, you'll continue to receive your usual medical care from your own doctors.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as potentially helping to develop a new way to prevent foot ulcers, which could improve care for many people with diabetes in the future. You'll also receive specific training on using the FeetSee device and ongoing support from the study team. There aren't many direct risks associated with using the camera itself, as it's a non-invasive device. The main commitment is the time and effort involved in taking daily foot images. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Lancashire Teaching Hospitals NHS Foundation Trust
Lancaster, United Kingdom
Manchester University NHS Foundation Trust (MFT)
Manchester, United Kingdom

Common questions

What is a 'thermal camera'?

It's a special camera that 'sees' heat. It can show warmer areas on your feet that might be a sign of inflammation.

Why do I need to have nerve damage in my feet?

Nerve damage means you might not feel pain from foot problems, so this camera could help spot issues you otherwise wouldn't notice.

Do I still see my regular doctor during the study?

Yes, you will continue to receive all your normal medical care from your own healthcare team throughout the study.

How long will I be in the study?

You'll be asked to use the device daily for about 6 to 9 months, or until a new foot ulcer appears.

What happens if a 'hot spot' is found on my foot?

The study aims to improve the analysis of these 'hot spots' but is not designed to directly tell you. You should always discuss new symptoms or concerns with your regular healthcare provider.

How to find out more

Helena Grinberg Rashi, Phd

helena@diabetis.lt +31615636666 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.