RecruitingNAINTERVENTIONAL

Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada

This study aims to discover if a particular home-use laser device, named B-Cure Laser, can speed up the healing of diabetic foot ulcers. Diabetic foot ulcers are common in people with diabetes and can be hard to treat. All participants will continue their usual medical care for their ulcer. In addition, some will receive the B-Cure Laser device to use at home, while others will receive a 'dummy' laser device that looks and feels the same but doesn't have the active laser. Researchers will regularly check the ulcers to see which group's wounds heal better and faster. The goal is to find out if this simple, at-home laser treatment can be an effective way to improve healing for people with diabetic foot ulcers.

At a glance

Status

Recruiting

Phase

Sponsor

Scarborough Rouge Hospital

Enrolment target

Start

01 Feb 2019

Estimated completion

01 Oct 2026

Diabetic Foot Ulcer

What is this study about?

If you have diabetes, you might know that foot ulcers can be a real problem. These sores on the feet can be tough to heal and need careful attention. This study is exploring a new way to help these ulcers get better more quickly using a special type of laser called B-Cure Laser Pro. This isn't a strong laser that you might think of for surgery, but a low-level light therapy that some believe can help the body heal itself.

The idea behind the study is to see if using this laser device at home, alongside your regular treatment for the ulcer, can make a difference. Some people in the study will get the actual B-Cure Laser Pro to use, while others will get a 'sham' device. A sham device looks and feels exactly like the real one but doesn't have the active laser. This helps the researchers fairly compare the active laser's effects against just the standard care.

The study aims to find out if adding this simple, at-home laser treatment can lead to faster healing for diabetic foot ulcers. If it does, it could offer a new and convenient way for people to manage their ulcers and improve their quality of life.

Key takeaways

This study explores a new home-use laser for diabetic foot ulcers.
It aims to see if the laser helps ulcers heal faster than standard care alone.
You might receive the active laser or a 'dummy' device.
Regular home use of the device and study visits are required.
Your standard ulcer care will continue throughout the study.
You can leave the study at any time without affecting your medical treatment.

Who may be eligible?

To join this study, you need to be an adult between 18 and 95 years old, male or female, and have type 1 or type 2 diabetes. You must also have a diabetic foot ulcer on your ankle or below, which has been present for at least 3 months and is at least 2 square centimetres in size after any initial cleaning. Your ulcer also needs to be a certain type (Wagner grade 2 or higher) and have good blood flow to the area.

You or your caregiver must be able to regularly change your wound dressings at home. If you're a woman who could become pregnant, you'll need to use effective birth control during the study. You'll also need to be willing to follow all the study instructions and attend all appointments.

There are also some reasons why you might not be able to join. These include if you have cancer, severe anaemia, uncontrolled diabetes (HbA1c over 12%), or plan to have certain surgeries on your blood vessels. You also can't join if you've recently had radiation or chemotherapy, are taking medicines that weaken your immune system, or have recently used other wound healing treatments. Having a history of alcohol or drug abuse within the last 6 months, being pregnant, or already taking part in another clinical study that might affect these results would also mean you can't participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 95 years old?
Do you have type 1 or type 2 diabetes?
Do you have a diabetic foot ulcer on your ankle or below that has been there for at least 3 months?
Is your ulcer at least the size of a 2cm x 1cm rectangle after cleaning?
Can you or a caregiver apply dressings and use a device at home?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to receive your usual medical care for your diabetic foot ulcer. In addition, you'll be randomly assigned to use either the active B-Cure Laser Pro device or a 'sham' (dummy) device at home. You or your caregiver will be taught how to use this device and apply it to your ulcer. You'll need to use it regularly as instructed.

Throughout the study, your wound will be checked by the study team every 2 weeks to see how it's healing. Any unexpected side effects or problems that occur will also be noted down. The study will continue for a period of time necessary to track your ulcer's healing, involving regular visits to monitor your progress.

Potential risks and benefits

Participating in this study might offer the potential benefit of faster healing for your diabetic foot ulcer if you receive the active laser treatment. However, there's no guarantee that the laser will be effective for everyone, or even at all. This is an investigational treatment, meaning its benefits and risks are still being studied. Potential risks are generally low with low-level lasers, but as with any medical device, there could be unforeseen side effects, or irritation to the skin. You might also experience the inconvenience of regular device use and study visits. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Scarborough Health Network ; Centenary Site
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'diabetic foot ulcer'?

It's an open sore or wound on the foot that can affect people with diabetes, often due to nerve damage and poor blood circulation.

What is the B-Cure Laser Pro?

It's a small, home-use device that uses low-level laser light, which is thought to help the body's natural healing processes.

Will I know if I'm getting the real laser or the 'sham' device?

No, you won't know if you're getting the active or 'sham' device. This is to ensure the study results are fair and unbiased.

How often will I need to use the laser device?

The study team will give you clear instructions on how often and for how long to use the device at home.

What if my ulcer gets worse during the study?

Your ulcer will be regularly monitored, and you will continue to receive your standard medical care, including management if your condition changes.

How to find out more

Rose Raizman, MSc, MScN

shoshray@gmail.com +1-416-8862328 Official trial record

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