Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
NCT03451188 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76
Last updated 2021-12-13
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.
Conditions
- Eds, Unspecified Type
Interventions
- DEVICE
-
Cerecare compression garments
all Cerecare compression garments
Sponsors & Collaborators
-
Cerecare
lead INDUSTRY
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-22
- Primary Completion
- 2020-06-26
- Completion
- 2021-11-30
- FDA Device
- Yes
Countries
- France
Study Locations
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