Eds, Unspecified TypeNCT03451188
Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
An observational study of Eds, Unspecified Type, run by Cerecare at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Eds, Unspecified Type
- What is being tested?
- Cerecare compression garments
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 5 sitesFrance
- Study dates
- 22 May 2018to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: EDS patient
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Dr Pontier
Clermont-Ferrand, 63100
Dr Benistan
Garches, 92380
Dr Michot
Paris, 75015
Dr Enjalbert
Perpignan
SLB Pharma
Rennes, 35000
About this study
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.
Read more
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.
- Conditions
- Eds, Unspecified Type
- Being tested
- Cerecare compression garments
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerecare compression garmentsDevice
all Cerecare compression garments
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
Joint pain assessment
Assessment of joint pain by an VAS (Visual Analog Scale) [0-100mm]: shoulder, elbow, wrist, finger, hip, knee, ankle.
Measured: 6, 12, 18 and 24 months
Daily monitoring of joint instability
Daily monitoring of joint instability as sprain, dislocation and subluxation (shoulder, elbow, wrist, finger, hip, knee, ankle).
Measured: 6, 12, 18 and 24 months
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).
Measured: 6, 12, 18 and 24 months
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.
Measured: 6, 12, 18 and 24 months
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).
Measured: 6, 12, 18 and 24 months
Tiredness
Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].
Measured: 6, 12, 18 and 24 months
Patient's quality of life
Assessment of Life quality by the SF-12 questionnaire (Short Form questionnaire on quality of life with 12 items).
Measured: 6, 12, 18 and 24 months
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.
Measured: 6, 12, 18 and 24 months
Compliance
By questioning the patient, estimate the number of hours of compression garments daily use.
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start22 May 2018
- Primary completion26 Jun 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eds, Unspecified TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451188
- Sponsor's protocol ID
- SEDCARE
- Status last verified
- Dec 2021
- First submitted
- 23 Jan 2018
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
- ClinicalTrials.gov ID
- NCT03451188
- Acronym / sponsor ID
- SEDCARE
- Conditions
- Eds, Unspecified Type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CerecareIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- EDS patient
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerecare compression garmentsall Cerecare compression garments | Device | – |
Primary outcome
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.
9 secondary outcomes
Joint pain assessment
Time frame: 6, 12, 18 and 24 months
Daily monitoring of joint instability
Time frame: 6, 12, 18 and 24 months
Neuropathic pain assessment
Time frame: 6, 12, 18 and 24 months
Proprioception disorders
Time frame: 6, 12, 18 and 24 months
Functional independence assessment
Time frame: 6, 12, 18 and 24 months
Tiredness
Time frame: 6, 12, 18 and 24 months
Patient's quality of life
Time frame: 6, 12, 18 and 24 months
Tolerance: incidence of Treatment-Emergent Adverse Events
Time frame: 6, 12, 18 and 24 months
Compliance
Time frame: 6, 12, 18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eds, Unspecified Type, run by Cerecare at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint pain assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.