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Trial record 7 of 31 for:    Ehlers-Danlos Syndrome

Efficiency Clinical Study of NOVATEX MEDICAL Pressure Garments in Patients With Ehlers-Danlos Syndrome (NOVASED)

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ClinicalTrials.gov Identifier: NCT03330977
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
EVAMED
Information provided by (Responsible Party):
Novatex Medical

Brief Summary:

Objective of this study is to assess the efficiency of NOVATEX MEDICAL pressure garments in patients with an Ehlers-Danlos syndrome (EDS).

To answer this objectif a comparison before/after use of pressure garments will be performed for all patients.


Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Pressure Garments Device: Pressure garments Not Applicable

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 pressure garments and presure garments prescription
  • V2: 8 months after inclusion, clinical evaluation with pressure garments
  • V3: 14 months after inclusion, clinical evaluation with pressure garments
  • V4: 20 months after inclusion, clinical evaluation with pressure garments
  • V5: 26 months after inclusion, clinical evaluation with pressure garments

Only the first two visits are specific to the study to be able to compare before and after the use of pressure garments. Next visits are the usual visits (every 6 months) for the use of pressure garments in patients with an EDS.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Comparison before/after
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency Clinical Study of NOVATEX MEDICAL Pressure Garments in Patients With Ehlers-Danlos Syndrome
Estimated Study Start Date : November 15, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Before and after use of pressure garments

At inclusion, patients will only have medication prescription as usual but without pressure garments, and thus, for 4 months.

4 months after inclusion, patients will continue medication but will also be prescribed pressure garments Then every 6 months, until 26 months, patients will come back to have new pressure garments (as usual practice)

Device: Pressure garments

Patients will wear the pressure garments since 4 months after inclusion in order to have a comparison before and after use.

Usual practice would give to the patient the pressure garments at inclusion.





Primary Outcome Measures :
  1. Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months [ Time Frame: month 4, month 8 ]

    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.



Secondary Outcome Measures :
  1. Patient characteristics [ Time Frame: Inclusion ]
    Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type

  2. Relative improvement of Functional Independence Measure (FIM) scale at 8 months [ Time Frame: month 4, month 8 ]

    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.


  3. Evolution of Functional Independence Measure (FIM) scale at long-term from inclusion at 14 months, 20 months and 26 months [ Time Frame: Inclusion, month 14, month 20, month 26 ]

    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


  4. Evolution of Pain (before and after pressure garments using) [ Time Frame: Inclusion, month 4, month 8, month 14, month 20, month 26 ]

    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.


  5. Evolution of Tiredness from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) [ Time Frame: Inclusion, month 4, month 8, month 14, month 20, month 26 ]

    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.


  6. Evolution of Anxiety and depression from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) [ Time Frame: Inclusion, month 4, month 8, month 14, month 20, month 26 ]

    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.


  7. Evolution of Quality of Life from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) [ Time Frame: Inclusion, month 4, month 8, month 14, month 20, month 26 ]

    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.


  8. Evolution of the Use of concomitant medication from inclusion at each visit (4 months, 8 months, 14 months, 20 months, 26 months) [ Time Frame: Inclusion, month 4, month 8, month 14, month 20, month 26 ]

    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.


  9. Evolution of Compliance [ Time Frame: Month 8, month 14, month 20, month 26 ]

    Compliance of pressure garments wearing using a patient notebook

    Proportion of patients who are compliant with the pressure garments wearing will be calculated at each visit.

    To be compliant is defined by a continuous or daily use


  10. Pressure garments safety [ Time Frame: month 26 ]
    All adverse events related to the pressure garments wearing from inclusion to 26 months will be presented and described

  11. Evolution of Patient satisfaction [ Time Frame: month 8, month 14, month 20, month 26 ]

    Patient satisfaction regarding pressure garments will be calculated at each visit using the following scale :

    • very satisfied
    • satisfied
    • not satisfied
    • very not satisfied



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 pressure garments
  • Patient for whom pressure 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 pressure 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330977


Contacts
Contact: Roland Jaussaud, Prof. +33 3 83 15 48 00 R.JAUSSAUD@chru-nancy.fr

Sponsors and Collaborators
Novatex Medical
EVAMED

Responsible Party: Novatex Medical
ClinicalTrials.gov Identifier: NCT03330977     History of Changes
Other Study ID Numbers: 2016-A01531-50
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Ehlers-Danlos Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases