Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

Cerecare

Status: Completed

Conditions: Eds, Unspecified Type

Treatments: Device: Cerecare compression garments

Study type: Observational

Funder types: Industry

Identifiers

NCT03451188

SEDCARE

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.