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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Based on the provided clinical trial data, there are no specific medications listed in the source data to describe. The trial compares compression therapy alone versus compression therapy combined with antibiotics for treating recurrent erysipelas, but specific antibiotic names are not provided in the source data. Without specific medication names, I cannot create the requested medication descriptions in the format you specified. If you would like medication descriptions, please provide the specific antibiotic names used in this clinical trial.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513801-30-00Protocol codeDR230313Estimated enrolment200 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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