An observational study in Eds, Unspecified Type, sponsored by Cerecare. Completed at 5 sites in France. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-12-13.
Sponsored by Cerecare · Observational
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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 2018, is one of 6 observational ones, and was the 4th 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: 16 Years and older · 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 2018.
This study's enrollment of 76 is below the median of 150 across 33 observational 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 Cerecare as lead sponsor.
Cerecare 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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EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility.
The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient.
The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect.
The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.
EDS patient
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
all Cerecare compression garments
Joint pain assessment
Assessment of the most painful joint by an VAS (Visual Analog Scale) \[0-100mm\]. The most painful joint at 0 months (= before use Compression Garments) will be choose as the primary outcome measure. The primary outcome measure will be done at 6 months.
Time frame: 6 months
Joint pain assessment
Assessment of joint pain by an VAS (Visual Analog Scale) \[0-100mm\]: shoulder, elbow, wrist, finger, hip, knee, ankle.
Time frame: 6, 12, 18 and 24 months
Daily monitoring of joint instability
Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle).
Time frame: 6, 12, 18 and 24 months
Neuropathic pain assessment
Assessment of neuropathic pain by the PAIN Detect questionnaire. The PAIN Detect questionnaire contains: * 3 numerical scales (NS) \[0-10\], * 7 items with categorical response (never, hardly noticed, slightly, moderately, strongly, very strongly).
Time frame: 6, 12, 18 and 24 months
Proprioception disorders
Assessment of proprioception disorders by the Berg Balance Scale (BBS) \[0-56\]. The BBS contains 14 items; each item is scored from 0 to 4.
Time frame: 6, 12, 18 and 24 months
Functional independence assessment
Assessment of functional independence by the Functional Independence Measure (FIM) \[18-126\]. The FIM contains 18 items; each item is scored from 1 (total assistance) to 7 (complete independence).
Time frame: 6, 12, 18 and 24 months
Tiredness
Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) \[1-7\].
Time frame: 6, 12, 18 and 24 months
Patient's quality of life
Assessment of Life quality by the SF-12 questionnaire (Short Form questionnaire on quality of life with 12 items).
Time frame: 6, 12, 18 and 24 months
Tolerance: incidence of Treatment-Emergent Adverse Events
By questioning the patient and by a medical exam, evaluation of adverse effect due to compression garments (Yes/ No): itch, edema, blister, redness, dermal ulceration.
Time frame: 6, 12, 18 and 24 months
Compliance
By questioning the patient, estimate the number of hours of compression garments daily use.
Time frame: 6, 12, 18 and 24 months
Ran from May 2018 to primary completion in Jun 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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