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Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever (ECHOPERY)

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ClinicalTrials.gov Identifier: NCT03917277
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Erysipelas Device: Musculoskeletal ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
Experimental: Musculoskeletal ultrasound of the ankle
see "Intervention description"
Device: Musculoskeletal ultrasound

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:

  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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Comparison of sonographic and radiographic findings between both ankles [ Time Frame: Within 24 hours of the onset of ELE ]
    Compare findings on musculoskeletal ultrasound and radiography between the ankle ipsilateral and contralateral to ELE.

  2. Sonographic evaluation of soft tissue thickness of the ankle [ Time Frame: Within 24 hours of the onset of ELE ]
    Measure and compare soft tissue thickness between the ankle ipsilateral and contralateral to ELE

  3. Correlation of sonographic findings with patients' characteristics [ Time Frame: Within 24 hours of the onset of ELE ]
    Correlate presence of musculoskeletal ultrasound pathologies of the ankle ipsilateral to ELE with clinical and paraclinical parameters.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917277


Contacts
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Contact: Sophie GEORGIN-LAVIALLE, MD ,PhD +33 1 56 01 60 77 sophie.georgin-lavialle@aphp.fr
Contact: Gilles GRATEAU, MD, PhD +33 1 56 01 60 77 gilles.grateau@aphp.fr

Locations
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France
Service de Médecine Interne Not yet recruiting
Paris, France, 75020
Contact: Sophie GEORGIN-LAVIALLE, MD PhD    +33 1 56 01 60 77    sophie.georgin-lavialle@aphp.fr   
Contact: KArine LOUATI, MD    +33 1 49 28 25 20    karine.louati@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Sophie GEORGIN-LAVIALLE, MD PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Karine LOUATI, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03917277     History of Changes
Other Study ID Numbers: APHP190233
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Erysipelas-like erythema
Familial Mediterranean Fever
Musculoskeletal ultrasound
Additional relevant MeSH terms:
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Brucellosis
Erysipelas
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Erythema
Signs and Symptoms
Skin Diseases
Skin Manifestations
Gram-Negative Bacterial Infections
Bacterial Infections
Genetic Diseases, Inborn
Skin Diseases, Genetic
Streptococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection