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

NCT03330977 | Unknown DMC

• 1 other identifier: 2016-A01531-50
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 10

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.

Conditions

Ehlers-Danlos Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient characteristics

  Inclusion

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

  month 4, month 8

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

  Inclusion, month 14, month 20, month 26

• Evolution of Pain (before and after compression garments using)

  Inclusion, month 4, month 8, month 14, month 20, month 26

• Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months)

  Inclusion, month 4, month 8, month 14, month 20, month 26

Study Arms (1)

Before and after use of compression garments

OTHER

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)

Device: Compression garments

Interventions

Compression garments 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.

Before and after use of compression garments

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novatex Medical: lead
• EVAMED: collaborator

Study Sites (10)

Centre Médical ISM

Boulogne-Billancourt, 92100, France

Location

CHU de CAEN

Caen, 14033, France

Location

Hopital Saint Joseph

Marseille, 13285, France

Location

Chu de Marseille - Hôpital de La Conception

Marseille, 13385, France

Location

Hôpital de L'Hotel Dieu - Aphp

Paris, 75004, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital de La Croix Saint Simon

Paris, 75020, France

Location

CHU de REIMS

Reims, 51100, France

Location

CHU de SAINT QUENTIN

Saint-Quentin, 02321, France

Location

CHRU de NANCY

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Roland Jaussaud, Prof.

  Hôpitaux de Brabois - CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison before/after

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: December 21, 2017
• Primary Completion: April 30, 2021
• Study Completion: March 31, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)