An interventional study of Compression garments in Ehlers-Danlos Syndrome, sponsored by Novatex Medical. Status unknown at 10 sites in France. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Novatex Medical · Not applicable, Interventional, and Treatment
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Among 13 studies in Ehlers-Danlos Syndrome with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Ehlers-Danlos Syndrome · France.
Among the 13 studies in Ehlers-Danlos Syndrome with a site in France, this one is the only one that started in 2017, is one of 6 with no phase, and was the 3rd registered.
67 studies on the registry are indexed under Ehlers-Danlos Syndrome; 24 are open to participants now.
Browse Ehlers-Danlos Syndrome studies →3 of the 13 studies in Ehlers-Danlos Syndrome with a site in France are open now. Recruiting first, the newest first:
Centre Medical ISM (Integrative Systemic Medicine) · Sites in France
Ages 18+
University Hospital, Rouen · Sites in France
Ages 18–50 · Women only · Healthy volunteers
GCS Ramsay Santé pour l'Enseignement et la Recherche · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 12 Ehlers-Danlos Syndrome studies recruiting now, 9 (75%) set no upper age limit and 3 (25%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 15 Years to 60 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2017.
This study's enrollment of 106 is above the median of 60 across 32 interventional studies indexed under Ehlers-Danlos Syndrome.
Median enrollment 48 across the 7 interventional studies, 116 across the 6 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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3 of 13 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Novatex Medical as lead sponsor.
Novatex Medical has 1 study filed under Ehlers-Danlos Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Ehlers-Danlos Syndrome with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07637084Centre Medical ISM (Integrative Systemic Medicine)Photobiomodulation for Chronic Pain and Fatigue in Hypermobile Ehlers-Danlos Syndrome (PBM-SEDh-01) | 2027-03-31 |
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Among the 13 studies in Ehlers-Danlos Syndrome with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Inclusion period: 1 year Follow-up period: 26 months Study period : 38 months
Patient visits will be organized as follow:
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: month 4, month 8
Patient characteristics
Describe the characteristics of included patients: age, gender, height, weight, profession, Ehlers-Danlos Syndrom type
Time frame: 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.
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
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
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.
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)
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.
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)
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.
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)
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.
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)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: month 8, month 14, month 20, month 26
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Apr 2021, 40 months after the start.
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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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