Comparison of compression therapy alone versus compression therapy with phenoxymethylpenicillin for preventing recurrent erysipelas in lower limbs

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What is this study about?

This clinical trial focuses on Recurrent Erysipelas, a bacterial skin infection that repeatedly affects the lower legs. The study aims to determine if using compression therapy alone works as well as using compression therapy combined with the antibiotic phenoxymethylpenicillin to prevent the infection from coming back.

The treatment will involve two different approaches. One group will receive only compression therapy, which involves wearing special tight stockings or bandages on the legs. The other group will receive both compression therapy and phenoxymethylpenicillin tablets taken by mouth. The antibiotic treatment can last up to 12 months.

During the study, which lasts for one year, doctors will monitor how well each treatment works in preventing the infection from returning. They will also look at other factors such as skin health, quality of life, and how often patients use their assigned treatments. This will help determine if using compression therapy alone can be as effective as using both compression and antibiotics together.

1 Initial assessment

You will be evaluated for participation in a study comparing two treatments for recurrent erysipelas (a type of skin infection) in lower limbs

The study duration is planned from October 2025 to October 2029

Your eligibility will be confirmed based on having at least 2 episodes of erysipelas in the same leg within the past 52 weeks

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Compression therapy only

Group 2: Compression therapy plus phenoxymethylpenicillin (oral antibiotic medication)

3 Treatment period

The treatment period will last for 1 year

You will need to maintain compression therapy throughout the study period

If assigned to Group 2, you will also take oral antibiotics as prescribed

You will need to keep a daily record of compression therapy use in a patient book

If taking antibiotics, you will need to record the days when medication is taken

4 Monitoring and assessments

Regular measurements of leg circumference will be taken to assess swelling

Your quality of life will be evaluated using specific questionnaires

Any skin changes or complications will be monitored

Any side effects or serious reactions will be recorded

If hospitalization is required, the number of nights will be documented

5 Study completion

The main outcome will be measuring how many patients experience at least one recurrence of erysipelas during the year

The effectiveness of both treatments will be compared

The study will also evaluate the cost-effectiveness of both treatment approaches

Who Can Join the Study?

  • Must be a man or woman aged 18 years or older
  • Must have experienced at least 2 episodes of erysipelas (a skin infection causing redness and swelling) in the same leg within the past 52 weeks
  • Must have had no more than 5 episodes of erysipelas in the same areas of the lower limbs during the past year
  • The most recent episode of erysipelas must have occurred within the past 3 months
  • Must have a Body Mass Index (BMI) below 40 kg/m² (BMI is a measure of body fat based on height and weight)
  • Must be able to apply compression bandages either independently or with help from another person (such as a nurse or family member)
  • Must be able to attend follow-up visits throughout the study period
  • Must be registered with a social security system
  • Must be able to understand the study requirements and provide written informed consent
  • Must be able to follow study instructions and comply with study requirements

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Current active erysipelas infection (a severe skin infection causing redness, swelling and pain)
  • Allergies to compression materials
  • Severe arterial circulation problems in legs
  • Deep vein thrombosis (blood clots in deep veins)
  • Current antibiotic treatment
  • Pregnancy or breastfeeding
  • Severe kidney or liver disease
  • Uncontrolled diabetes
  • Active skin conditions other than erysipelas
  • History of poor compliance with medical treatments
  • Inability to follow study procedures
  • Participation in other clinical trials
  • Conditions that may interfere with compression therapy
  • Severe leg deformities that prevent proper compression

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De La Reunion St Denis France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
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Fundkzfhk Cbjseiq Jiq Paris France
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Hyshfmey Uwrulrrdiiduez Sldpmsffqj &cjxfpw Hetwrni dm Hpoqrgvvbsr STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.10.2025

Trial locations

Compression therapy is a treatment that involves applying special bandages or garments to the legs to improve blood flow and reduce swelling. This therapy helps prevent skin infections and is commonly used for various leg conditions.

Penicillin is an antibiotic medication used to prevent and treat bacterial skin infections. In cases of erysipelas (a type of skin infection), it helps prevent the infection from recurring by fighting the bacteria that cause the condition.

Both treatments are used to prevent the recurrence of erysipelas, which is a bacterial skin infection that causes redness, swelling, and pain, most commonly affecting the legs. While compression therapy works by improving circulation and reducing swelling, antibiotics work by fighting the bacteria that cause the infection.

Erysipelas – A bacterial skin infection that typically affects the legs, causing redness, swelling, and warmth in the affected area. The condition develops when bacteria, usually streptococcus, enter through small breaks in the skin and spread in the upper layers of the skin. Erysipelas often causes the affected skin to appear raised, with a clear border between infected and normal tissue. The condition can become recurrent, meaning it may return multiple times in the same area, particularly in the lower limbs. People with poor circulation, lymphedema, or other conditions affecting the legs are more susceptible to developing recurrent erysipelas.

Trial ID:
2024-513801-30-00
Protocol code:
DR230313
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to evaluate the safety and effectiveness of dalbavancin in patients with erysipelas or limited cellulitis being treated at home.

    Not yet recruiting

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    Investigated drugs:
    Austria