ErysipelasECHOPERYNCT03917277
Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever
A study testing Musculoskeletal ultrasound in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erysipelas
- What is being tested?
- Musculoskeletal ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patient followed by the National reference center for autoinflammatory diseases and inflammatory amyloidosis (CeRéMAIA) at Tenon Hospital in Paris
- Patient with a diagnosis of FMF based on Livneh criteria and supported by 2 pathogenic MEFV mutations
- Patient with unilateral ankle ELE for less than 24 hours and whose diagnosis is confirmed a posteriori by its spontaneous resolution in 72 hours
- Patient affiliated or entitled to an affiliation to a social security system
- Provision of informed consent
Who cannot join
- Incapacity to answer questions, express him(her)self clearly, or collaborate with the performance of the musculoskeletal ultrasound
- Previous surgery, significant trauma, destructive arthropathy, and any other pathology affecting the musculoskeletal structures of the ankle and thus influencing its sonographic examination
- Previous diagnosis of gout
- Current pregnancy
- Patient deprived of liberty or under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne
Paris, 75020
Sophie GEORGIN-LAVIALLE, MD PhD, +33 1 56 01 60 77, sophie.georgin-lavialle@aphp.fr
KArine LOUATI, MD, +33 1 49 28 25 20, karine.louati@aphp.fr
About this study
Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. In order to support this hypothesis, ankle musculoskeletal ultrasound will be performed within 24 hours of onset of ELE in 15 patients diagnosed with FMF. Results will be correlated with clinical parameters, serum inflammatory markers, and ankle radiography.
Read the detailed description
Erysipelas-like erythema (ELE) is the pathognomonic cutaneous manifestation of familial Mediterranean fever (FMF). It typically presents with painful, well-demarcated, and unilateral erythema overlying the ankle, and resolves spontaneously within 24 to 72 hours. Its incidence varies from 1% to 48% in the literature, depending on gender and ethnicity. Joint involvement during FMF is more common than ELE, affecting between 17% and 77% of patients. It is most often monoarticular and involves the ankles in almost half of cases. Concomitant ELE is described in up to 43% of patients. However, the overlap between the clinical presentation of ELE and ankle arthritis in FMF poses a diagnostic challenge.
Musculoskeletal ultrasound is a simple and sensitive technique for the evaluation of articular and peri-articular structures. Only one study described sonographic articular involvement in FMF. In 29 asymptomatic patients, an increased prevalence of knee effusion, retrocalcaneal bursitis and medial tenosynovitis of the ankle was noted compared with the control group. Irrespective of joint involvement, an increased prevalence of enthesopathy has also been documented by ultrasound in patients with FMF, thus strengthening its association with spondyloarthropathy. However, no study has evaluated by ultrasound the articular and peri-articular involvement of the ankle during an episode of ELE. To date, the treatment of ELE involves ankle offloading and administration of analgesics. By allowing a better understanding of its pathogenesis, sonographic confirmation of articular and peri-articular involvement of the ankle during an episode of ELE will potentially allow to optimize its therapeutic management.
The study population involves over 600 patients with FMF followed at Tenon Hospital, which is part of the French Reference center for rare auto-inflammatory diseases and amyloidosis (CEREMAIA). Eligible patients will be contacted by mail or email to inform them of the study. Those interested in participating will be advised to contact the investigators by email or phone at the onset of ELE. Patients presenting with ELE during their visit in the internal medicine department of Tenon Hospital will also be screened for eligibility.
A visit between the participant and attending physician will be scheduled within 24 hours of the onset of ELE. The usual management of ELE will not be altered. The visit will include a questionnaire and physical examination to assess the presence of typical manifestations of FMF attacks, such as chest and/or abdominal pain, as well as to exclude systemic toxicity in favor of an alternative infectious diagnosis. It will involve a blood test for complete blood count and C-reactive protein measurement to confirm the inflammatory syndrome, as well as an x-ray of the ankles to exclude an underlying structural pathology. Analgesics will be prescribed for symptomatic relief. The patient will be advised to go the emergency room if ELE and/or fever persist beyond 72 hours, or if symptoms suggestive of an infectious process develop (significant worsening of general state, cardiorespiratory symptoms, pre-syncope or syncope, etc).
The inclusion visit for the study will be integrated to this medical consultation. Once free and informed consent is obtained, the following clinical data will be collected: age, sex, weight, height, body mass index, ethnicity, age at onset of FMF symptoms, age at diagnosis of FMF, genotype, frequency of attacks, diagnosis of amyloidosis, spondyloarthropathy, inflammatory bowel disease and/or vasculitis, previous episodes of ankle arthritis, duration and location of ELE at inclusion, total duration of ELE, presence of fever, serositis and/or myalgia, and current treatment for FMF. In search of potential confounding factors for sonographic musculoskeletal abnormalities, the following data will also be collected: professional occupation, physical activity (type and frequency), presence of pes planus or cavus, pre-existing ankle pain, and chronic ankle edema. Sonographic evaluation of the articular and periarticular structures of the two ankles will be performed using the Samsung UGEO H60 echograph, in operation since 2016. In order to ensure reproducibility, the evaluation will be completed by a single examiner throughout the study.
Following the inclusion visit, a follow-up by email or phone will be done within one week of inclusion in order to confirm the exact duration of ELE. This information will allow us to confirm the diagnosis of ELE, which normally resolves spontaneously within 72 hours, in contrast to its main differential diagnosis, namely erysipelas. Thereafter, there will be no additional follow-up as part of this study.
The patient inclusion phase will last 8 months, followed by 3 months of data analysis. We estimate that 8 months will be sufficient to recruit 15 patients among our study population. The number 15 was arbitrarily chosen because FMF is a rare disease, and the incidence of ELE in this population is highly variable and therefore poorly defined in the literature.
Regarding data analysis, clinical, biological, radiographic and sonographic data will be presented as medians (± interquartile interval) when these are continuous variables, and as absolute numbers with proportion when these are categorical variables. Sonographic and radiographic findings will be compared between the ankles ipsilateral and contralateral to ELE. Continuous variables will be compared with the Mann-Whitney test. Categorical variables will be compared with the Fisher test. In order to determine whether clinical and paraclinical parameters are correlated with the presence of sonographic musculoskeletal pathologies, univariate and multivariate analyses will be performed using a logistic regression model. A p value ≤ 0.05 will be considered statistically significant.
- Conditions
- Erysipelas
- Being tested
- Musculoskeletal ultrasound
- Keywords
- Erysipelas-like erythema, Familial Mediterranean Fever, Musculoskeletal ultrasound
- Medical subject headings
- Erysipelas, Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal ultrasoundDevice
Ankle sonographic examination will be performed using Samsung UGEO H60 ultrasound machine in use since 2016. In order to optimize reproducibility, all examinations will be performed by a single examiner. Multiplanar (longitudinal/transverse) scanning will be done in B- and PD-mode to identify pathologies defined by the OMERACT network in the following structures:
- Talocrural joint:synovial fluid (scored 0-3);synovitis with synovial hypertrophy and PD signal (each scored 0-3); bone erosion with distance between cortices and presence/absence of DP signal
- Tibialis anterior,tibialis posterior, extensor digitorum longus, fibularis brevis,fibularis tertius,and calcaneal tendons: presence/absence of tenosynovitis, thickening, hypoechogenicity, nodularity, fusiform aspect, and DP signal
- Calcaneal enthesis: presence/absence of thickening,hypoechogenicity,calcification, cortical irregularity,and DP signal
- Retrocalcaneal and calcaneal bursa: presence/absence of bursitis and DP signal
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal ultrasound of the ankle | Experimental | see "Intervention description" Receives: Device: Musculoskeletal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal ultrasound evaluation of the ankle
Presence of one or more of the following musculoskeletal pathologies identified by sonographic examination of the ankle: synovial fluid, synovitis, and/or bone erosions in the talocrural joint; tendinous anomalies in the tibialis anterior, tibialis posterior, extensor digitorum longus, fibularis brevis, fibularis tertius, and calcaneal tendons; calcaneal enthesopathy, and retrocalcaneal and calcaneal bursitis.
Measured: Within 24 hours of the onset of ELE
Secondary outcomes (3)
Comparison of sonographic and radiographic findings between both ankles
Compare findings on musculoskeletal ultrasound and radiography between the ankle ipsilateral and contralateral to ELE.
Measured: Within 24 hours of the onset of ELE
Sonographic evaluation of soft tissue thickness of the ankle
Measure and compare soft tissue thickness between the ankle ipsilateral and contralateral to ELE
Measured: Within 24 hours of the onset of ELE
Correlation of sonographic findings with patients' characteristics
Correlate presence of musculoskeletal ultrasound pathologies of the ankle ipsilateral to ELE with clinical and paraclinical parameters.
Measured: Within 24 hours of the onset of ELE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErysipelasStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie GEORGIN-LAVIALLE, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisKarine LOUATI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917277
- Sponsor's protocol ID
- APHP190233
- Acronym
- ECHOPERY
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT03917277
- Acronym / sponsor ID
- ECHOPERY / APHP190233
- Conditions
- Erysipelas
- Keywords
- Erysipelas-like erythema, Familial Mediterranean Fever, Musculoskeletal ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. In order to support this hypothesis, ankle musculoskeletal ultrasound will be performed within 24 hours of onset of ELE in 15 patients diagnosed with FMF. Results will be correlated with clinical parameters, serum inflammatory markers, and ankle radiography.
Detailed description
Erysipelas-like erythema (ELE) is the pathognomonic cutaneous manifestation of familial Mediterranean fever (FMF). It typically presents with painful, well-demarcated, and unilateral erythema overlying the ankle, and resolves spontaneously within 24 to 72 hours. Its incidence varies from 1% to 48% in the literature, depending on gender and ethnicity. Joint involvement during FMF is more common than ELE, affecting between 17% and 77% of patients. It is most often monoarticular and involves the ankles in almost half of cases. Concomitant ELE is described in up to 43% of patients. However, the overlap between the clinical presentation of ELE and ankle arthritis in FMF poses a diagnostic challenge.
Musculoskeletal ultrasound is a simple and sensitive technique for the evaluation of articular and peri-articular structures. Only one study described sonographic articular involvement in FMF. In 29 asymptomatic patients, an increased prevalence of knee effusion, retrocalcaneal bursitis and medial tenosynovitis of the ankle was noted compared with the control group. Irrespective of joint involvement, an increased prevalence of enthesopathy has also been documented by ultrasound in patients with FMF, thus strengthening its association with spondyloarthropathy. However, no study has evaluated by ultrasound the articular and peri-articular involvement of the ankle during an episode of ELE. To date, the treatment of ELE involves ankle offloading and administration of analgesics. By allowing a better understanding of its pathogenesis, sonographic confirmation of articular and peri-articular involvement of the ankle during an episode of ELE will potentially allow to optimize its therapeutic management.
The study population involves over 600 patients with FMF followed at Tenon Hospital, which is part of the French Reference center for rare auto-inflammatory diseases and amyloidosis (CEREMAIA). Eligible patients will be contacted by mail or email to inform them of the study. Those interested in participating will be advised to contact the investigators by email or phone at the onset of ELE. Patients presenting with ELE during their visit in the internal medicine department of Tenon Hospital will also be screened for eligibility.
A visit between the participant and attending physician will be scheduled within 24 hours of the onset of ELE. The usual management of ELE will not be altered. The visit will include a questionnaire and physical examination to assess the presence of typical manifestations of FMF attacks, such as chest and/or abdominal pain, as well as to exclude systemic toxicity in favor of an alternative infectious diagnosis. It will involve a blood test for complete blood count and C-reactive protein measurement to confirm the inflammatory syndrome, as well as an x-ray of the ankles to exclude an underlying structural pathology. Analgesics will be prescribed for symptomatic relief. The patient will be advised to go the emergency room if ELE and/or fever persist beyond 72 hours, or if symptoms suggestive of an infectious process develop (significant worsening of general state, cardiorespiratory symptoms, pre-syncope or syncope, etc).
The inclusion visit for the study will be integrated to this medical consultation. Once free and informed consent is obtained, the following clinical data will be collected: age, sex, weight, height, body mass index, ethnicity, age at onset of FMF symptoms, age at diagnosis of FMF, genotype, frequency of attacks, diagnosis of amyloidosis, spondyloarthropathy, inflammatory bowel disease and/or vasculitis, previous episodes of ankle arthritis, duration and location of ELE at inclusion, total duration of ELE, presence of fever, serositis and/or myalgia, and current treatment for FMF. In search of potential confounding factors for sonographic musculoskeletal abnormalities, the following data will also be collected: professional occupation, physical activity (type and frequency), presence of pes planus or cavus, pre-existing ankle pain, and chronic ankle edema. Sonographic evaluation of the articular and periarticular structures of the two ankles will be performed using the Samsung UGEO H60 echograph, in operation since 2016. In order to ensure reproducibility, the evaluation will be completed by a single examiner throughout the study.
Following the inclusion visit, a follow-up by email or phone will be done within one week of inclusion in order to confirm the exact duration of ELE. This information will allow us to confirm the diagnosis of ELE, which normally resolves spontaneously within 72 hours, in contrast to its main differential diagnosis, namely erysipelas. Thereafter, there will be no additional follow-up as part of this study.
The patient inclusion phase will last 8 months, followed by 3 months of data analysis. We estimate that 8 months will be sufficient to recruit 15 patients among our study population. The number 15 was arbitrarily chosen because FMF is a rare disease, and the incidence of ELE in this population is highly variable and therefore poorly defined in the literature.
Regarding data analysis, clinical, biological, radiographic and sonographic data will be presented as medians (± interquartile interval) when these are continuous variables, and as absolute numbers with proportion when these are categorical variables. Sonographic and radiographic findings will be compared between the ankles ipsilateral and contralateral to ELE. Continuous variables will be compared with the Mann-Whitney test. Categorical variables will be compared with the Fisher test. In order to determine whether clinical and paraclinical parameters are correlated with the presence of sonographic musculoskeletal pathologies, univariate and multivariate analyses will be performed using a logistic regression model. A p value ≤ 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal ultrasound of the ankle | Experimental | Device: Musculoskeletal ultrasoundsee "Intervention description" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Patient followed by the National reference center for autoinflammatory diseases and inflammatory amyloidosis (CeRéMAIA) at Tenon Hospital in Paris
- Patient with a diagnosis of FMF based on Livneh criteria and supported by 2 pathogenic MEFV mutations
- Patient with unilateral ankle ELE for less than 24 hours and whose diagnosis is confirmed a posteriori by its spontaneous resolution in 72 hours
- Patient affiliated or entitled to an affiliation to a social security system
Key exclusion criteria (5 listed)
- Incapacity to answer questions, express him(her)self clearly, or collaborate with the performance of the musculoskeletal ultrasound
- Previous surgery, significant trauma, destructive arthropathy, and any other pathology affecting the musculoskeletal structures of the ankle and thus influencing its sonographic examination
- Previous diagnosis of gout
- Current pregnancy
- Patient deprived of liberty or under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musculoskeletal ultrasoundAnkle sonographic examination will be performed using Samsung UGEO H60 ultrasound machine in use since 2016. In order to optimize reproducibility, all examinations will be performed by a single examiner. Multiplanar (longitudinal/transverse) scanning will be done in B- and PD-mode to identify pathologies defined by the OMERACT network in the following structures: 1. Talocrural joint:synovial fluid (scored 0-3);synovitis with synovial hypertrophy and PD signal (each scored 0-3); bone erosion with distance between cortices and presence/absence of DP signal 2. Tibialis anterior,tibialis posterior, extensor digitorum longus, fibularis brevis,fibularis tertius,and calcaneal tendons: presence/absence of tenosynovitis, thickening, hypoechogenicity, nodularity, fusiform aspect, and DP signal 3. Calcaneal enthesis: presence/absence of thickening,hypoechogenicity,calcification, cortical irregularity,and DP signal 4. Retrocalcaneal and calcaneal bursa: presence/absence of bursitis and DP signal | Device | Musculoskeletal ultrasound of the ankle |
Primary outcome
Musculoskeletal ultrasound evaluation of the ankle
Time frame: Within 24 hours of the onset of ELE
Presence of one or more of the following musculoskeletal pathologies identified by sonographic examination of the ankle: synovial fluid, synovitis, and/or bone erosions in the talocrural joint; tendinous anomalies in the tibialis anterior, tibialis posterior, extensor digitorum longus, fibularis brevis, fibularis tertius, and calcaneal tendons; calcaneal enthesopathy, and retrocalcaneal and calcaneal bursitis.
3 secondary outcomes
Comparison of sonographic and radiographic findings between both ankles
Time frame: Within 24 hours of the onset of ELE
Sonographic evaluation of soft tissue thickness of the ankle
Time frame: Within 24 hours of the onset of ELE
Correlation of sonographic findings with patients' characteristics
Time frame: Within 24 hours of the onset of ELE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Related trials for Erysipelas
Not yet recruitingPhase 4
Prophylaxis of Recurrent Erysipelas in Lower Limbs: compreSsion thErapy vs aNTibiotics and Compression Therapy.
Recurrent Erysipelas
Not yet recruitingPhase 4
Comparing Short to Standard Amoxicillin Course for Erysipelas
Erysipelas
Recruiting
Hospital at Home for Elderly Acute Ill Patients
Cystitis, Erysipelas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie GEORGIN-LAVIALLE, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Karine LOUATI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musculoskeletal ultrasound in people with Erysipelas, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie GEORGIN-LAVIALLE, MD,PhD (+33 1 56 01 60 77, sophie.georgin-lavialle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal ultrasound evaluation of the ankle (time frame: Within 24 hours of the onset of ELE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.