RecruitingInterventional

The evaluation of MedCu copper wound dressing, compared to standard care, for management of foot and leg ulcers

This study is testing a new wound dressing called MedCu, which contains copper, for people with foot and leg ulcers. Copper is thought to help kill germs and heal wounds. Researchers want to see if this special dressing works better than the usual dressings hospitals provide. If you have a leg or foot ulcer that’s between 1 and 30 square centimetres in size, and has been present for more than 30 days but less than a year, you might be able to join. The study will compare patients using the copper dressing with those receiving standard care. It's hoped this will help doctors decide the best way to treat these ulcers in the future.

At a glance

Status

Recruiting

Sponsor

North Cumbria Integrated Care NHS Foundation Trust

Enrolment target

Start

23 Apr 2025

Estimated completion

31 Aug 2026

Leg ulcer

What is this study about?

When you have a leg or foot ulcer, healthcare professionals use special dressings to help it heal and prevent infection. This study wants to find out if a newer dressing, called MedCu, which contains tiny amounts of copper, works better than the usual dressings you might get. Copper is interesting because it's known to kill bacteria, and there's some early evidence that it might also help wounds get better faster. However, we need more studies to be sure it truly helps in real-life NHS care.

This study will compare the MedCu dressing with what's called 'standard care'. Standard care means the typical dressings your healthcare team would usually choose for your ulcer. Sometimes this is a regular dressing, and sometimes it might be another type of dressing designed to kill germs, like one that contains silver. By comparing these two approaches, researchers hope to get a clear picture of whether the MedCu dressing offers advantages.

Taking part means you would be randomly put into one of two groups: one receiving the MedCu dressing and one receiving standard care. 'Randomly' means like drawing names out of a hat, so it's a fair way to see which treatment works best. The goal is to see if MedCu can improve how ulcers heal, reduce infections, or make you more comfortable. The results will help doctors and nurses decide the best ways to treat people with foot and leg ulcers in the future.

Key takeaways

This study compares a new copper dressing (MedCu) to usual care for leg and foot ulcers.
It aims to see if copper helps wounds heal or prevents infection.
Adults with specific sized leg/foot ulcers can take part.
Participation involves random assignment to one of two dressing groups and 4 visits over 12 weeks.
Risks are expected to be low, as treatments are similar to standard care.
You can stop participating at any time.

Who may be eligible?

The study is looking for adults aged 18 or older who have a leg or foot ulcer. If you are a woman, you must be past menopause (no longer having periods).

Your ulcer needs to be a certain size – between 1 and 30 square centimetres. This is roughly the size of a small fingernail up to a credit card. It also needs to have been there for more than 30 days but less than one year since you first noticed it.

You cannot join if you are under 18, cannot understand what taking part means, have a very serious illness that limits your life expectancy, or have been treated with strong antibiotics for your ulcer in the last week. You also can't be in another study for your ulcer or have already taken part in a previous copper dressing study.

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 18 years old or older?
If you are a woman, are you past menopause?
Is your leg or foot ulcer between 1 and 30 square centimetres in size?
Has your ulcer been present for more than 30 days but less than a year?
Have you not received strong antibiotics for your ulcer in the last week?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to give your written consent, meaning you understand and agree to participate. Then, you'll be randomly assigned to one of two groups: either you'll receive the new MedCu copper dressing, or you'll receive the standard dressing chosen by your care team.

You will have appointments at the start (week 0), and then again at 4, 8, and 12 weeks. At these appointments, the doctors or nurses will check your ulcer and how it's healing. They'll assess things like its size and appearance. The study will last for 12 weeks from when you start receiving the dressing, but the team will explain the full timeline to you.

Potential risks and benefits

The treatments used in this study are very similar to what you might receive as part of your normal care, so serious risks are expected to be very low. The main benefit is the chance that one of the dressings being tested could be more effective for your ulcer, but we don't know this yet, which is why the study is happening. You won't receive any payments for taking part. There's a very small chance a dressing could cause skin irritation, or extremely rarely, an allergic reaction to copper. If you join and new important information comes up, the study team will let you know immediately. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Cumbria Integrated Care NHS Foundation Trust
City only
Carlisle, England

Common questions

What is a leg or foot ulcer?

It's an open sore on your leg or foot that doesn't heal easily, often needing special care.

Why is copper being used in a dressing?

Copper is known to kill germs and may help wounds heal, so researchers want to test if a copper dressing is better than standard ones.

Will I know which dressing I'm getting?

You will be randomly assigned to either the copper dressing or standard care. The medical team will explain which group you are in.

How long will I be in the study?

Your involvement in the study will be for 12 weeks after you start receiving the dressing.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your future medical care.

How to find out more

Leon Jonker

Leon.jonker@ncic.nhs.uk +44 (0)1228 814668 Official trial record

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