NCT03330977

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Novatex Medical · Industry
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ehlers-Danlos Syndrome

Interventions

Type	Name	Description
DEVICE	Compression garments	Patients will wear the compression garments since 4 months after inclusion in order to have a comparison before and after use. Usual practice would give to the patient the compression garments at inclusion.

Timeline

• Start date: 2017-12-21
• Primary completion: 2021-04-30
• Completion: 2023-03-31
• First posted: 2017-11-06
• Last updated: 2021-03-23

Locations

10 sites across 1 country: France