Clinical trial NCT03451188: Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Official title: Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eds, Unspecified Type
Lead sponsor: Cerecare
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EDS patient

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Ehlers-Danlos syndrome diagnosis confirmed by a medical specialist, according to the new diagnostic criteria of 2017,
* Articular hyperlaxity,
* Have not used compression garments for at least 1 year,
* Without expected body weight change within 6 months,
* Having agreed to participate in the study

Exclusion Criteria:

* Presenting a known allergy to the components of compression garments,
* Presenting acute and unusual pain, not medically controlled,
* Pregnant woman,
* Participating simultaneously with another study or having recently participated in another study for which the exclusion period would not be completed.

Primary outcomes:
measure: Joint pain assessment
timeFrame: 6 months
Secondary outcomes:
measure: Joint pain assessment
timeFrame: 6, 12, 18 and 24 months
measure: Daily monitoring of joint instability
timeFrame: 6, 12, 18 and 24 months
measure: Neuropathic pain assessment
timeFrame: 6, 12, 18 and 24 months
measure: Proprioception disorders
timeFrame: 6, 12, 18 and 24 months
measure: Functional independence assessment
timeFrame: 6, 12, 18 and 24 months
measure: Tiredness
timeFrame: 6, 12, 18 and 24 months
measure: Patient's quality of life
timeFrame: 6, 12, 18 and 24 months
measure: Tolerance: incidence of Treatment-Emergent Adverse Events
timeFrame: 6, 12, 18 and 24 months
measure: Compliance
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Dr Pontier
city: Garches
country: France
facility: Dr Benistan
city: Paris
country: France
facility: Dr Michot
city: Perpignan
country: France
facility: Dr Enjalbert
city: Rennes
country: France
facility: SLB Pharma
Study officials:
References: