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

Novatex Medical106 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Ehlers-Danlos Syndrome

Interventions

Compression garmentsDEVICE

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (10)

Centre Médical ISM

Boulogne-Billancourt, France

CHU de CAEN

Caen, France

Hopital Saint Joseph

Marseille, France

Chu de Marseille - Hôpital de La Conception

Marseille, France

Outcomes

Primary Outcomes

Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months

Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are \[18;126\]. More the score is high, better is the independence. The proportion of patients who present an improvement of 10% of the FIM score between 4 months and 8 months will be calculated.

Time frame: month 4, month 8

Secondary Outcomes

Patient characteristics

Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type

Time frame: Inclusion

Relative improvement of Functional Independence Measure (FIM) scale at 8 months

Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are \[18;126\]. More the score is high, better is the independence. The FIM score at 8 months will be compared to the FIM score at 4 months.

Time frame: month 4, month 8

Evolution of Functional Independence Measure (FIM) scale at long-term from inclusion at 14 months, 20 months and 26 months

Functional Independence Measure (FIM) is an 18- Item of physical, psychological and social function. The FIM uses the level of assistance an individual needs to grade the functional status of a person. For each item, disability level is coded from 1 (Total Assistance or not Testable) to 7 (Complete Independence) A total score is calculated using an addition of all items. Thus, score ranges are \[18;126\]. More the score is high, better is the independence. The FIM score will be described at each visit and if relevant, compared to FIM score at inclusion

Data from ClinicalTrials.gov

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