Clinical trial NCT03330977: Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
Official title: Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ehlers-Danlos Syndrome
Lead sponsor: Novatex Medical
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2017-11-06
Enrollment: 106
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison before/after
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months
timeFrame: month 4, month 8
Secondary outcomes:
measure: Patient characteristics
timeFrame: Inclusion
measure: Relative improvement of Functional Independence Measure (FIM) scale at 8 months
timeFrame: month 4, month 8
measure: Evolution of Functional Independence Measure (FIM) scale at long-term from inclusion at 14 months, 20 months and 26 months
timeFrame: Inclusion, month 14, month 20, month 26
measure: Evolution of Pain (before and after compression garments using)
timeFrame: Inclusion, month 4, month 8, month 14, month 20, month 26
measure: Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)
timeFrame: Inclusion, month 4, month 8, month 14, month 20, month 26
measure: Evolution of Anxiety and depression from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)
timeFrame: Inclusion, month 4, month 8, month 14, month 20, month 26
measure: Evolution of Quality of Life from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)
timeFrame: Inclusion, month 4, month 8, month 14, month 20, month 26
measure: Evolution of the Use of concomitant medication from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)
timeFrame: Inclusion, month 4, month 8, month 14, month 20, month 26
measure: Evolution of Compliance
timeFrame: Month 8, month 14, month 20, month 26
measure: Compression garments safety
timeFrame: month 26
measure: Evolution of Patient satisfaction
timeFrame: month 8, month 14, month 20, month 26
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Centre Médical ISM
city: Caen
country: France
facility: CHU de CAEN
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: Chu de Marseille - Hôpital de La Conception
city: Paris
country: France
facility: Hôpital de L'Hotel Dieu - Aphp
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital de La Croix Saint Simon
city: Reims
country: France
facility: CHU de REIMS
city: Saint-Quentin
country: France
facility: CHU de SAINT QUENTIN
city: Vandoeuvre les nancy
country: France
facility: CHRU de NANCY
Study officials:
affiliation: Hôpitaux de Brabois - CHRU de Nancy
name: Roland Jaussaud, Prof.
role: PRINCIPAL_INVESTIGATOR
References: