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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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

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Ehlers-Danlos Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Comparison before/after

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Before and after use of compression garments

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)

Group Type OTHER

Compression garments

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No