Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03451188|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : November 9, 2018
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|
|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|
- Device: Cerecare compression garments
all Cerecare compression garments
- 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.
- 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.
- 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).
- 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).
- 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.
- 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).
- Tiredness [ Time Frame: 6, 12, 18 and 24 months ]Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].
- 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).
- 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.
- Compliance [ Time Frame: 6, 12, 18 and 24 months ]By questioning the patient, estimate the number of hours of compression garments daily use.
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
|Contact: Ophélie Flageulfirstname.lastname@example.org|
|Clermont-Ferrand, France, 63100|
|Contact: Bénédicte Pontier, Dr|
|Garches, France, 92380|
|Contact: Karelle Benistan, Dr|
|Dr Michot||Active, not recruiting|
|Paris, France, 75015|
|Contact: Michel Enjalbert, Dr|
|Sub-Investigator: Catherine Leblond, Dr|
|SLB Pharma||Not yet recruiting|
|Rennes, France, 35000|
|Contact: Ophélie Flageul email@example.com|
|Principal Investigator: Karelle Benistan, Dr|