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

NCT07549594 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: DR230313
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Recurrent Erysipelas

Keywords

Supervised compression; Oral penicillin; Controlling relapse of erysipelas; Randomized non-inferiority clinical trial

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least one recurrence of erysipelas during the 1-year prophylaxis phase, performed by a assessor-blinded

  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 Outcomes (9)

• Time to the first confirmed recurrence of erysipelas

  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)

  From enrollment to the end of treatment at 12 months

• Severity of recurrence: presence of skin necrosis or ulceration

  From enrollment to the end of treatment at 12 months

• Assessment of adverse effects and serious adverse effects during the study

  From enrollment to the end of treatment at 12 months

• Quality of life: Dermatology Life Quality Index (DLQI)

  Month 0, Month 3, Month 6, Month 9, Month 12 and in case of potential recurrence, e.g.up to 52 weeks

Study Arms (2)

Experimental arm : supervised compression therapy + emollient cream during 12 months

EXPERIMENTAL

Device: elastic stockings

Control group: supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpé

ACTIVE COMPARATOR

Device: elastic stockings; Drug: Phenoxymethylpenicillin

Interventions

elastic stockings DEVICE

thighs-high stockings, produced by means of circular knitting, corresponding to the patient's measurements

Control group: supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpé; Experimental arm : supervised compression therapy + emollient cream during 12 months

Phenoxymethylpenicillin DRUG

Phenoxymethylpenicillin (Oracilline) 1 Million UI twice a day, per os, during one year

Control group: supervised compression therapy + emollient cream + oral penicillin (phénoxyméthylpé

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (25)

AMIENS

Amiens, France

Location

Bordeaux-D

Bordeaux, France

Location

Bordeaux-I

Bordeaux, France

Location

TOURS-D

Chambray-lès-Tours, France

Location

CRETEIL

Créteil, France

Location

DIJON

Dijon, France

Location

GRENOBLE

La Tronche, France

Location

LE MANS

Le Mans, France

Location

Lille Ghicl

Lille, France

Location

LYON

Lyon, France

Location

NANTES-D

Nantes, France

Location

NANTES-I

Nantes, France

Location

ORLEANS

Orléans, France

Location

Paris Cognacq-Jay

Paris, France

Location

Paris La Pitie

Paris, France

Location

Paris St Louis-I

Paris, France

Location

Paris St-Antoine-I

Paris, France

Location

POITIERS

Poitiers, France

Location

REIMS

Reims, France

Location

RENNES-D

Rennes, France

Location

ROUEN

Rouen, France

Location

St-Etienne

Saint-Etienne, France

Location

La Reunion

Saint-Pierre, France

Location

Strasbourg

Strasbourg, France

Location

TOURS-I

Tours, France

Location

MeSH Terms

Conditions

Erysipelas

Interventions

Stockings, Compression; Penicillin V

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Loïc VAILLANT

CONTACT

0247479080; loic.vaillant@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (25)