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Completed

NCT Number: NCT03451188

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.

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Key information

Conditions

Eds, Unspecified Type Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Ehlers-Danlos Syndrome Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Pontier, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cerecare compression garments

Device

all Cerecare compression garments

Primary outcomes

  1. Joint pain assessment

    Time frame: 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 outcomes

  1. Joint pain assessment

    Time frame: 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.

  2. Daily monitoring of joint instability

    Time frame: 6, 12, 18 and 24 months

    Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle).

  3. Neuropathic pain assessment

    Time frame: 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).

  4. Proprioception disorders

    Time frame: 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.

  5. Functional independence assessment

    Time frame: 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).

  6. Tiredness

    Time frame: 6, 12, 18 and 24 months

    Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].

  7. Patient's quality of life

    Time frame: 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).

  8. Tolerance: incidence of Treatment-Emergent Adverse Events

    Time frame: 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.

  9. Compliance

    Time frame: 6, 12, 18 and 24 months

    By questioning the patient, estimate the number of hours of compression garments daily use.

Sponsors and collaborators

Lead sponsor

Cerecare

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 1, 2018
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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