AuthorisedTherapeutic use (Phase IV)Interventional

A superiority study comparing two pharmaceutical skin care creams containing different humectants with a non-humectant containing skin care cream for the treatment of xerotic foot of persons with diabetes.

This study is looking at two different skin creams to treat dry, cracked skin on the feet, a common problem for people with diabetes. We want to find out if these special creams, called Oviderm and Canoderm, are better than a basic cream at improving foot dryness over a four-week period. We'll be carefully checking how well they reduce dryness and how comfortable people feel. We'll also be looking at how the creams affect the skin's natural protective barrier and if there are any side effects. This research aims to help find better ways to care for diabetic foot skin.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Malmö Universitet

Enrolment target

Start

31 Jul 2023

xerotic skin on foot of subjects with diabetes

What is this study about?

If you have diabetes, you might find that the skin on your feet can get very dry, cracked, and uncomfortable. This is called xerosis. This study wants to help people like you by testing two specific skin creams – Oviderm and Canoderm – to see if they can make a real difference. These creams contain special moisturising ingredients that are designed to help your skin hold onto water and stay more supple.

We are comparing these two creams against a standard cream that doesn't have these special moisturisers. Our main goal is to see if Oviderm and Canoderm can reduce the dryness on your feet more effectively than the standard cream after just four weeks of use. We'll be using a special scale to measure how dry and cracked your skin is at the start and then again after treatment.

Beyond just looking at dryness, we'll also be checking how the creams affect the health of your skin's protective barrier. This barrier is really important for keeping moisture in and irritants out. We'll use gentle, non-invasive tools to measure things like how much water your skin loses and how hydrated it is. We'll also ask about your general quality of life to see if feeling more comfortable helps you in other ways. And, of course, we'll be carefully watching out for any unexpected effects to make sure the creams are safe.

Key takeaways

This study tests two creams for dry, cracked feet in people with diabetes.
It lasts four weeks and involves applying a cream daily.
Researchers will check how well the creams reduce dryness and help skin barrier.
It aims to find better ways to care for diabetic foot skin.
Your general comfort and safety will be monitored throughout.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. We are looking for both men and women.

The most important thing is that you have diabetes and are currently experiencing dry, cracked skin on your feet that needs treatment. This study is specifically designed for people with this condition.

There might be other health conditions or treatments that could affect whether you can join, but the research team will discuss all of these details with you to make sure it's safe and suitable for you.

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?
Do you have a diagnosis of diabetes?
Do you currently have dry, cracked skin on your feet that needs treatment?
Are you comfortable attending regular clinic visits for four weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of the skin creams (Oviderm, Canoderm, or the standard cream) to use on your feet for four weeks. You'll need to apply the cream as instructed by the study team. Over these four weeks, you will have a few visits to the clinic. During these visits, the research team will examine your feet to assess the dryness, take measurements of your skin's hydration and barrier function, and ask you about how you are feeling and your comfort levels. They will also check your general health, including things like your blood pressure. The total duration of your participation will be four weeks, plus any initial screening visits.

Potential risks and benefits

Taking part in this study could potentially help improve the dryness and comfort of your feet with one of the trial creams. Your participation will also help us understand more about how different creams work for dry diabetic feet, which could benefit many others in the future. As with any cream, there's a small chance you might experience some skin irritation or an allergic reaction; the study team will monitor you closely for any unwanted effects. You are free to withdraw from 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.

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Unverified
Sweden

Common questions

What is 'xerotic skin'?

It's a medical term for very dry, scaly, and sometimes cracked skin, often found on the feet of people with diabetes.

What kind of creams are being tested?

Two special creams, Oviderm and Canoderm, are being compared to a standard cream. They all aim to relieve dry skin on the feet.

How long will I use the cream for?

If you join the study, you will use the assigned cream on your feet for a total of four weeks.

Will I know which cream I am using?

Often in studies like this, participants don't know which cream they are getting until the end. This is to make sure the results are fair and unbiased.

What if I have side effects from the cream?

The study team will carefully monitor you for any side effects. If you experience any issues, you should let them know immediately. Your safety is their priority.