AuthorisedTherapeutic confirmatory (Phase III)Interventional

PRESENT - Prophylaxis of Recurrent Erysipelas in lower limbs: compreSsion thErapy vs aNTibiotics and compression therapy. A non-inferiority, randomized, multicenter clinical trial.

This research study, called PRESENT, is exploring the best ways to prevent repeat episodes of a skin infection called erysipelas in people's legs. Erysipelas can be painful and keep coming back, so finding effective ways to stop it is very important. The study compares two approaches: using special compression bandages by themselves, versus using compression bandages alongside antibiotics. The main goal is to see if using just compression bandages is as good as using both treatments together in stopping the infection from returning over a year. This type of study can help doctors understand which long-term treatment plan works best for patients, aiming to improve their health and quality of life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

200

Start

07 Jul 2025

Recurrent Erysipelas in lower limbs

What is this study about?

Many adults who have had erysipelas in their legs find that it can return again and again. Erysipelas causes red, swollen, and painful skin and can sometimes lead to hospital stays. Because it keeps coming back for some people, doctors are looking for the most effective and practical ways to prevent these repeat infections.

This study, called PRESENT, is designed to compare two different ways of stopping erysipelas from returning in the legs. One group of participants will use special compression bandages on their legs, which help with swelling and circulation. The other group will use these same compression bandages and also take a specific antibiotic called phenoxymethylpenicillin. The main aim is to find out if compression bandages alone are as good at preventing future infections as using both bandages and antibiotics together for one year.

The information gathered from this study will help healthcare professionals understand which long-term treatment strategy is best for patients. It will also look at how these treatments affect quality of life, how severe any new infections might be, and whether there are any side effects. Ultimately, the goal is to improve how erysipelas is managed, helping people avoid recurrent infections and live healthier lives.

Key takeaways

This study evaluates treatments to stop erysipelas returning in legs.
It compares compression bandages alone versus with antibiotics.
The goal is to find the most effective long-term prevention.
Participants will be adults over 18 with recurrent leg erysipelas.
It's a one-year study with regular check-ups and monitoring.
Information gathered will help improve future patient care.

Who may be eligible?

This study is for adults over 18 years old who have experienced repeated episodes of erysipelas in their legs. Doctors will check your medical history to make sure you fit all the necessary requirements to take part safely.

Both men and women are welcome to participate in this research. The study aims to include a wide range of adults who suffer from recurrent erysipelas to ensure the results are helpful for many different people.

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?
Have you had erysipelas in your legs more than once?
Are you able to attend regular study appointments?
Are you willing to consider using either compression, or compression plus antibiotics, for a year?
Can you keep a simple record of your treatment (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups: one will use compression bandages, and the other will use compression bandages plus antibiotics. You would be in the study for about a year. During this time, you would have regular check-ups to see how you're doing and if the erysipelas returns. These check-ups will also monitor for any side effects from the medication or bandages. You'll be asked to keep a record of how often you wear your compression and, if applicable, how often you take your antibiotics. We'll also measure your leg swelling and ask questions about your quality of life.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving close medical monitoring for your erysipelas and access to potential new treatment approaches. However, all medical treatments carry some risks; for instance, antibiotics can have side effects, and compression therapy might cause skin irritation in some people. Your study doctor will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you have the right 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
France

Common questions

What is erysipelas?

Erysipelas is a skin infection, often in the legs, that causes red, swollen, and painful areas. It's similar to cellulitis.

Why is this study important?

It's important because many people suffer from recurrent erysipelas, and this study aims to find the best long-term way to prevent it from coming back.

What are compression bandages?

These are special bandages or stockings that apply pressure to your legs. They help to reduce swelling and improve blood flow.

Will I know if I'm taking antibiotics or just using compression?

The study aims to be 'blinded' in some ways, meaning some doctors assessing your condition won't know your treatment. You will know if you are taking antibiotics or not.

How long will I be in the study?

You will be part of the study for about one year, during which your condition will be monitored.