Ehlers-Danlos SyndromeNOVASEDNCT03330977
Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
A study testing Compression garments in people with Ehlers-Danlos Syndrome, run by Novatex Medical at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- Compression garments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 10 sitesFrance
- Study dates
- 21 Dec 2017to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Médical ISM
Boulogne-Billancourt, 92100
CHU de CAEN
Caen, 14033
Hopital Saint Joseph
Marseille, 13285
Chu de Marseille - Hôpital de La Conception
Marseille, 13385
Hôpital de L'Hotel Dieu - Aphp
Paris, 75004
Hopital Lariboisiere
Paris, 75010
Hopital de La Croix Saint Simon
Paris, 75020
CHU de REIMS
Reims, 51100
CHU de SAINT QUENTIN
Saint-Quentin, 02321
CHRU de NANCY
Vandœuvre-lès-Nancy, 54500
About this study
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.
Read the 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.
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- Compression garments
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Compression garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 4, month 8
Secondary outcomes (11)
Patient characteristics
Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type
Measured: 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.
Measured: 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
Measured: Inclusion, month 14, month 20, month 26
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.
Measured: 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)
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.
Measured: Inclusion, month 4, month 8, month 14, month 20, month 26
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.
Measured: Inclusion, month 4, month 8, month 14, month 20, month 26
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.
Measured: Inclusion, month 4, month 8, month 14, month 20, month 26
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.
Measured: Inclusion, month 4, month 8, month 14, month 20, month 26
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
Measured: Month 8, month 14, month 20, month 26
Compression garments safety
All adverse events related to the compression garments wearing from inclusion to 26 months will be presented and described
Measured: month 26
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
Measured: month 8, month 14, month 20, month 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start21 Dec 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison before/after
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novatex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Roland Jaussaud, Prof., Principal investigator, Hôpitaux de Brabois - CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330977
- Sponsor's protocol ID
- 2016-A01531-50
- Acronym
- NOVASED
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2017
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT03330977
- Acronym / sponsor ID
- NOVASED / 2016-A01531-50
- Conditions
- Ehlers-Danlos Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Novatex MedicalIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison before/after
| Arm | Type | Receives |
|---|---|---|
| Before and after use of compression garments | Other | Device: Compression garmentsAt 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) |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression garmentsPatients 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. | Device | Before and after use of compression garments |
Primary outcome
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.
11 secondary outcomes
Patient characteristics
Time frame: Inclusion
Relative improvement of Functional Independence Measure (FIM) scale at 8 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
Time frame: Inclusion, month 14, month 20, month 26
Evolution of Pain (before and after compression garments using)
Time frame: 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)
Time frame: Inclusion, month 4, month 8, month 14, month 20, month 26
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 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 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
Evolution of Compliance
Time frame: Month 8, month 14, month 20, month 26
Compression garments safety
Time frame: month 26
Evolution of Patient satisfaction
Time frame: month 8, month 14, month 20, month 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Jaussaud, Prof. principal investigator
Hôpitaux de Brabois - CHRU de Nancy
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression garments in people with Ehlers-Danlos Syndrome, run by Novatex Medical at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Functional Independence Measure (FIM) scale from 4 months at 8 months (time frame: month 4, month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.