Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome - Clinical Trial for Ehlers-Danlos Syndrome | NCT03330977

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Compression garments

About this trial

This is an interventional treatment trial for Ehlers-Danlos Syndrome

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Before and after use of compression garments

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient characteristics

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

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.

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

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.

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.

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.

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.

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.

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

Compression garments safety

All adverse events related to the compression garments wearing from inclusion to 26 months will be presented and described

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

Full Information

NCT ID

NCT03330977

First Posted

October 20, 2017

Last Updated

March 18, 2021

Sponsor

Novatex Medical

Collaborators

EVAMED

1. Study Identification

Unique Protocol Identification Number

NCT03330977

Brief Title

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

Acronym

NOVASED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 21, 2017 (Actual)

Primary Completion Date

April 30, 2021 (Anticipated)

Study Completion Date

March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novatex Medical

Collaborators

EVAMED

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ehlers-Danlos Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Comparison before/after

Masking

None (Open Label)

Allocation

N/A

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Before and after use of compression garments

Arm Type

Other

Arm Description

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)

Intervention Type

Device

Intervention Name(s)

Compression garments

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Patient characteristics

Description

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

Time Frame

Inclusion

Title

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

Description

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

Title

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

Description

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

Time Frame

Inclusion, month 14, month 20, month 26

Title

Evolution of Pain (before and after compression garments using)

Description

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.

Time Frame