Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy. (PRESENT)

April 17, 2026 updated by: University Hospital, Tours

Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy. A Non-inferiority, Multicentre, Randomized Clinical Trial.

Erysipelas (superficial cellulitis) is a frequent streptococcal bacterial infection. Each episode of erysipelas may worsen preexisting lymphedema and evolve to life-threatening necrotizing soft-tissue infection. Moreover, each attack of cellulitis may worsen lymphatic damage and therefore favour additional attacks. Recurrence is frequent: 10-30% of cases and even up to 50%. In this context, at least 2 episodes of erysipelas in the same limb during a 1-year period defines recurrent erysipelas requiring prophylaxis. Such prophylaxis is based usually on penicillin therapy. Compression was evaluated only in a monocentric randomized controlled trial, and was never compared to antibioprophylaxis.

The investigators hypothesized that compression therapy alone might represent a single intervention for prophylaxis of erysipelas recurrence as efficient as long-term antibiotic prophylaxis with compression therapy combined.

This study is a multicenter, parallel groups, assessor-blinded, non-inferiority, randomized clinical trial. Main objective is to evaluate whether supervised compression therapy alone is non-inferior to supervised compression therapy + oral penicillin in controlling relapse of recurrent erysipelas. Secondary objectives are to assess time to first recurrence ; to assess the severity of the recurrence ; to assess the safety of the intervention to assess the quality of life during the prophylaxis phase ; to assess the adherence of patients with the intervention and to assess, in a joint analysis, that supervised compression therapy is both not inferior in terms of QALY and not more expensive at 1 year than supervised compression therapy + antibiotic.

The study will included male or female adults who have had at least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization. Experimental group is supervised compression therapy + emollient cream during 12 months and control group is supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpénicilline) during 12 months Main outcome is the proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by an assessor-blinded.

Patients will be identified in a hospital setting, or referred by physicians servicing the local region, or by direct advertising through patients' associations. If the patient gives consent to participate, at the end of a inclusion visit (V0), the randomization will be performed via the e-CRF. Prescriptions will then be issued on inclusion. Control group who will start antibiotic treatment at inclusion. A run-in period of 7 ±2 days will be planned between V0 and the beginning of the compression therapy for the both group, in order to get the prescribed elastic stockings, and to train the nurse in charge of the compression supervision. A nurse trained in the study will supervise the first applications of the compression in the patient's home. After inclusion visit (V0), a home visit by the liberal IDE will be planned at M1 for to check daily adherence (use of ATB or/and wearing compression and application of emollients). A patient diary must be completed from inclusion and during the follow-up period. Two telemedicine clinic were scheduled at M3 and M9 and two study visits were scheduled at M6 and M12 with a complete physical examination. All the evaluations will be performed by a blinded evaluator investigator. Supplementary telemedicine clinic(s) in case of potential recurrence of erysipelas will be done by the blinded evaluator in the presence of the nurse who will be at bedside of patient.

The organization and design of the study will be realistic, and thus is designed to facilitate its feasibility and generalizability of results. In case of demonstration of non-inferiority of supervised compression therapy, patients with recurrent erysipelas will be spared of antibiotics first-line, and therefore suppress the impact of both long-term antibiotics on gut microbiota individuals and health burden of antibiotics at the population level.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female
  • ≥ 18 years of age
  • At least 2 episodes of recurrent erysipelas at the same leg within the previous 52 weeks, and no more than five episodes of erysipelas in the same areas of the lower limbs during the year before randomization
  • The last recurrent erysipelas have to be diagnosed within the previous 3 months
  • BMI < 40 kg/m2 (no morbid obesity)
  • Able to apply the compression alone or with a helper (e.g., nurse, household member)
  • Affiliated with a social security regimen
  • Able to consent and written informed consent obtained from the participant
  • Able to understand the aims of the study and to comply with the requirements of the study
  • Able to participate and be followed up during the study period

Exclusion Criteria:

  • Any causes of immunosuppression: known HIV+ infection, organ transplantation, bonemarrow transplantation, immunosuppressive regimens for any disease, malignancy or lymphoproliferative disorder
  • Receiving antibiotic treatment for erysipelas

  • Received antibiotic prophylaxis for recurrent erysipelas in the year before randomization

    _ Received short- or long-term antibiotic therapy for a condition other than erysipelas

  • Already wore effective compression therapy (worn at least 5 days a week) in the 3 months before randomization
  • Contraindication to compression therapy (ie heart failure, arterial occlusive disease,including obliterative peripheral arterial disease with a systolic pressure index < 0.6, advanced diabetic microangiopathy for compression > 30 mmHg, phlegmasia cerulea dolens, and septic thrombosis)
  • History of known hypersensitivity to beta-lactamines or contraindications to Phenoxymethylpenicillin (Oracilline) or to any of the other components of the medicine as per its SmPC
  • Contraindications to the emollient cream in accordance with its SmPC
  • Diabetic foot and fractures
  • Woman of childbearing potential not using a highly effective method of contraception*, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed in all woman of childbearing potential
  • Persons covered by articles L1121-5 to L1121-8 of the Code de Santé Publique (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship).
  • Participation in another interventional research with an investigational drug or medical device.
  • Mental state rendering the person giving consent incapable of understanding the trial;
  • Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm : supervised compression therapy + emollient cream during 12 months
Device: elastic stockings
thighs-high stockings, produced by means of circular knitting, corresponding to the patient's measurements
Active Comparator: Control group: supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpé
Device: elastic stockings
thighs-high stockings, produced by means of circular knitting, corresponding to the patient's measurements
Drug: Phenoxymethylpenicillin
Phenoxymethylpenicillin (Oracilline) 1 Million UI twice a day, per os, during one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded
Time Frame: From enrollment to the end of treatment at 12 months

Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded Diagnosis will be done by a blinded evaluator (investigator) different from those who recruited the patients, in the following 48h after the first sign of recurrence (fever, chills and/or erythematous plaque).

Recurrence of erysipelas will be diagnosed as sudden onset (<24h) of a well demarcated cutaneous inflammation (redness, warmth, edema and pain), with fever (>38°C) and/or chills
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the first confirmed recurrence of erysipelas
Time Frame: From enrollment to the first confirmed recurrence of erysipelas, e.g.up to 52 weeks
From enrollment to the first confirmed recurrence of erysipelas, e.g.up to 52 weeks
Severity of recurrence : erysipelas-related hospital admission (number of nights in hospital for cellulitis)
Time Frame: From enrollment to the end of treatment at 12 months
Erysipelas-related hospital admission : number of nights in hospital for cellulitis because treatment of erysipelas is normally an outpatient treatment, hospital admission is considered as a marker of severity of erysipelas.
From enrollment to the end of treatment at 12 months
Severity of recurrence: presence of skin necrosis or ulceration
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Assessment of adverse effects and serious adverse effects during the study
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Quality of life: Dermatology Life Quality Index (DLQI)
Time Frame: Month 0, Month 3, Month 6, Month 9, Month 12 and in case of potential recurrence, e.g.up to 52 weeks
Stantardized questionnaire with minimum value = 0 (better out come) and maximum value = 30 (worse outcome)
Month 0, Month 3, Month 6, Month 9, Month 12 and in case of potential recurrence, e.g.up to 52 weeks
Quality of life: EuroQuol-5 Dimensions-5 Levels standardised questionnaire (EQ-5D-5L)
Time Frame: Month 0, Month 3, Month 6, Month 9, Month12 and in case of potential recurrence
EQ-5D-5L (EuroQuol 5 Dimensions 5 Levels standardised questionnaire) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects.
Month 0, Month 3, Month 6, Month 9, Month12 and in case of potential recurrence
Adherence: number of days per week that compression was worn
Time Frame: From enrollment to the end of treatment at 12 months
Using a patient diary. Patients' adherence with compression therapy, which is known to be low
From enrollment to the end of treatment at 12 months
Adherence: assessment of oedema by circumferential measurements
Time Frame: Month 0, Month 6, Month 12
By evaluator (assessor-blinded during the follow-up) and devoted tool (excel calculator) will be built accordingly to give automatically the truncated cone formula
Month 0, Month 6, Month 12
Adherence: number of days per week that antibiotics is taken
Time Frame: From enrollment to the end of treatment at 12 months
Using a patient diary
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR230313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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