Eds, Unspecified Type Clinical Trial
Official title:
Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
| NCT number | NCT03451188 |
| Other study ID # | SEDCARE |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 22, 2018 |
| Est. completion date | November 30, 2021 |
| Verified date | December 2021 |
| Source | Cerecare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | November 30, 2021 |
| Est. primary completion date | June 26, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Dr Pontier | Clermont-Ferrand | |
| France | Dr Benistan | Garches | |
| France | Dr Michot | Paris | |
| France | Dr Enjalbert | Perpignan | |
| France | SLB Pharma | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Cerecare |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Tiredness | Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7]. | 6, 12, 18 and 24 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Compliance | By questioning the patient, estimate the number of hours of compression garments daily use. | 6, 12, 18 and 24 months |