Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome (NOVASED)

Novatex Medical

Status: Unknown

Conditions: Ehlers-Danlos Syndrome

Treatments: Device: Compression garments

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03330977

2016-A01531-50

Details and patient eligibility

About

Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS).

To answer this objectif a comparison before/after use of compression garments will be performed for all patients.

Full description

Inclusion period: 1 year Follow-up period: 26 months Study period : 38 months

Patient visits will be organized as follow:

• V0: first visit at inclusion, clinical evaluation
• V1: 4 months after inclusion, clinical evaluation without compression garments and presure garments prescription
• V2: 8 months after inclusion, clinical evaluation with compression garments
• V3: 14 months after inclusion, clinical evaluation with compression garments
• V4: 20 months after inclusion, clinical evaluation with compression garments
• V5: 26 months after inclusion, clinical evaluation with compression garments

Only the first two visits are specific to the study to be able to compare before and after the use of compression garments. Next visits are the usual visits (every 6 months) for the use of compression garments in patients with an EDS.

Enrollment: 106 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient between 15 and 60 years old
• Ehlers-Danlos Syndrome type: " classical ", " classical-like ", " hypermobile ", " arthrochalasia ", " kyphoscoliotic ", " musculocontractural " ou " myopathic ", as defined in the new international EDS classification 2017
• Patient who have never used compression garments
• Patient for whom compression garments will be prescribed at 4 months
• Patient who have dated and signed a consent form
• Patient who have understood the study
• Patient who are affiliated to French social health insurance system and/or in compliance with the recommendations of the national law in force relating to biomedical research

Exclusion criteria

• patient under guardianship or enabled to complete questionnaires
• pregnant or breastfeeding woman
• patient who presents allergy to one of compression garments components
• patient with a current medical history who promotes postural disorders
• patient with an asymptomatic "Hypermobile Sprectrum Disorder" type of EDS as defined in the new international EDS classification 2017
• patient with a current or recent (<3months) participation in another investigational study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Before and after use of compression garments

Other group

Description:

At inclusion, patients will only have medication prescription as usual but without compression garments, and thus, for 4 months. 4 months after inclusion, patients will continue medication but will also be prescribed compression garments Then every 6 months, until 26 months, patients will come back to have new compression garments (as usual practice)

Treatment:

Device: Compression garments