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

Completed

• Conditions: Eds, Unspecified Type

• Registration Number: NCT03451188
• Lead Sponsor: Cerecare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Study Start: 2018-05-22
• Primary Completion: 2020-06-26
• Study Completion: 2021-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Joint pain assessment	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Daily monitoring of joint instability	6, 12, 18 and 24 months	Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle).
Neuropathic pain assessment	6, 12, 18 and 24 months	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).
Proprioception disorders	6, 12, 18 and 24 months	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.
Tiredness	6, 12, 18 and 24 months	Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) \[1-7\].
Joint pain assessment	6, 12, 18 and 24 months	Assessment of joint pain by an VAS (Visual Analog Scale) \[0-100mm\]: shoulder, elbow, wrist, finger, hip, knee, ankle.
Patient's quality of life	6, 12, 18 and 24 months	Assessment of Life quality by the SF-12 questionnaire (Short Form questionnaire on quality of life with 12 items).
Tolerance: incidence of Treatment-Emergent Adverse Events	6, 12, 18 and 24 months	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.
Functional independence assessment	6, 12, 18 and 24 months	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).
Compliance	6, 12, 18 and 24 months	By questioning the patient, estimate the number of hours of compression garments daily use.

Trial Locations

Locations (5)

Dr Pontier; 🇫🇷 Clermont-Ferrand, France

Dr Benistan; 🇫🇷 Garches, France

Dr Enjalbert; 🇫🇷 Perpignan, France

Dr Michot; 🇫🇷 Paris, France

SLB Pharma; 🇫🇷 Rennes, France