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Trial record 16 of 31 for:    Ehlers-Danlos Syndrome

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

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ClinicalTrials.gov Identifier: NCT03451188
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Eds, Unspecified Type Device: Cerecare compression garments

Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Cerecare compression garments
    all Cerecare compression garments


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
EDS patient
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451188


Contacts
Contact: Ophélie Flageul +33299121962 o.flageul@slbpharma.com

Locations
France
Dr Pontier Recruiting
Clermont-Ferrand, France, 63100
Contact: Bénédicte Pontier, Dr         
Dr Benistan Recruiting
Garches, France, 92380
Contact: Karelle Benistan, Dr         
Dr Michot Active, not recruiting
Paris, France, 75015
Dr Enjalbert Recruiting
Perpignan, France
Contact: Michel Enjalbert, Dr         
Sub-Investigator: Catherine Leblond, Dr         
SLB Pharma Not yet recruiting
Rennes, France, 35000
Contact: Ophélie Flageul       o.flageul@slbpharma.com   
Principal Investigator: Karelle Benistan, Dr         
Sponsors and Collaborators
Cerecare

Responsible Party: Cerecare
ClinicalTrials.gov Identifier: NCT03451188     History of Changes
Other Study ID Numbers: SEDCARE
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases