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

Ehlers-Danlos Syndrome Clinical Trial

— NOVASED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03330977
• Other study ID #: 2016-A01531-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2021
• Source: Novatex Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: March 31, 2023
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Centre Médical ISM	Boulogne-Billancourt
France	CHU de CAEN	Caen
France	Chu de Marseille - Hôpital de La Conception	Marseille
France	Hopital Saint Joseph	Marseille
France	Hôpital de L'Hotel Dieu - Aphp	Paris
France	Hopital de La Croix Saint Simon	Paris
France	Hopital Lariboisiere	Paris
France	CHU de REIMS	Reims
France	CHU de SAINT QUENTIN	Saint-Quentin
France	CHRU de NANCY	Vandoeuvre les nancy

Sponsors (2)

Lead Sponsor	Collaborator
Novatex Medical	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	month 4, month 8
Secondary	Patient characteristics	Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type	Inclusion
Secondary	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.	month 4, month 8
Secondary	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	Inclusion, month 14, month 20, month 26
Secondary	Evolution of Pain (before and after compression garments using)	Pain evolution using the VAS scale (from 0=no pain to 100=worst imaginable pain) The pain VAS is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.; For each visit, proportion of patients who present a decrease of at least 30% of pain score from inclusion, or a pain score <= 2, will be calculated.	Inclusion, month 4, month 8, month 14, month 20, month 26
Secondary	Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)	Tiredness evolution using Pichot scale Eight items are coded from 0 to 4 (0 = not at all, 1 = a little 2 = moderately 3 = much 4 = extremely).; Lower is the score, better is the patient tiredness; For each visit, proportion of patients who present a decrease of at least 30% of Pichot score from inclusion, or a pichot score < 20, will be calculated.	Inclusion, month 4, month 8, month 14, month 20, month 26
Secondary	Evolution of Anxiety and depression from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)	Evolution using the HAD scale (Hospital Anxiety and Depression scale); 14 items are included in this scale divided in two sub-scores (7 for assessment of the depression and 7 for the assessment of anxiety). A total score is also calculated.; Lower is the score, better is the patient status; For each visit, proportion of patients who present a decrease of at least 30% of HAD score from inclusion, or a HAD score < 14, will be calculated.	Inclusion, month 4, month 8, month 14, month 20, month 26
Secondary	Evolution of Quality of Life from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)	Evolution of the Quality of Life using the EQ-5D-3L scale; This scale is composed of 5 items with 3 levels from 1 to 3.; Based on these levels, an index can be calculated from 0 to 1. Higher is the score, better is the patient status; For each visit, proportion of patients who present an improvement of at least 0.10 of index from inclusion will be calculated.	Inclusion, month 4, month 8, month 14, month 20, month 26
Secondary	Evolution of the Use of concomitant medication from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)	Assess the decreasing of use of concomitant medication; The proportion of patient who present a decreasing of concomitant medication will be calculated at each visit.	Inclusion, month 4, month 8, month 14, month 20, month 26
Secondary	Evolution of Compliance	Compliance of compression garments wearing using a patient notebook; Proportion of patients who are compliant with the compression garments wearing will be calculated at each visit.; To be compliant is defined by a continuous or daily use	Month 8, month 14, month 20, month 26
Secondary	Compression garments safety	All adverse events related to the compression garments wearing from inclusion to 26 months will be presented and described	month 26
Secondary	Evolution of Patient satisfaction	Patient satisfaction regarding compression garments will be calculated at each visit using the following scale : very satisfied; satisfied; not satisfied; very not satisfied	month 8, month 14, month 20, month 26