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

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.

Study Overview

• Status: Completed
• Conditions: Eds, Unspecified Type
• Intervention / Treatment: Device: Cerecare compression garments

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63100
    • Dr Pontier
  • Garches, France, 92380
    • Dr Benistan
  • Paris, France, 75015
    • Dr Michot
  • Perpignan, France
    • Dr Enjalbert
  • Rennes, France, 35000
    • SLB Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

EDS patient

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint pain assessment	Assessment of joint pain by an VAS (Visual Analog Scale) [0-100mm]: shoulder, elbow, wrist, finger, hip, knee, ankle.	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).	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).	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.	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).	6, 12, 18 and 24 months
Tiredness	Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].	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).	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.	6, 12, 18 and 24 months
Compliance	By questioning the patient, estimate the number of hours of compression garments daily use.	6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Cerecare

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Ehlers-Danlos Syndrome
• Other Study ID Numbers: SEDCARE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes