Ehlers-Danlos Syndrome Hypermobility TypeVETCOSEDNCT02144532
Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
A study testing short-sleeved vest CICATREX SED®) in people with Ehlers-Danlos Syndrome Hypermobility Type, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome Hypermobility Type
- What is being tested?
- short-sleeved vest CICATREX SED®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2014to 5 Apr 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ehlers-Danlos syndrome hypermobility type confirmed the diagnosis of a geneticist
- with an instability of one or both shoulders, painful or considered invalidating by the patient (recurrent dislocation or subluxation : at least once / month or at least 12 times / year)
- having a joint hypermobility syndrome (abnormal mobility and in a non-physiological axis), with a Beighton score of greater than or equal to 5 of 9
- age greater than or equal to 18 years
- size greater than or equal to 1 m 40
- sufficient understanding of the French language in order to respond to self-report questionnaires
Who cannot join
- hyperalgic episode in progress
- unstable cardiac disease
- previous history of shoulder surgery
- severe skin lesions,
- pregnancy in progress
Trial locations and contacts
1 site in 1 country.
France1 site
Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Lyon, 69322
About this study
Official title: Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived and the most crippling.
Faced with insufficient effect of drug treatment, other alternatives have been proposed to relieve these patients. Compression garments have been developed. They appear as medical devices targeted specifically for patients with hypermobility EDS type: in the symptomatic treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle globulization, and in the functional improvement.
Read more
The VETCOSED study is a quasi-experimental study of type "Before / After", monocentric, open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which they do not carry this garment.
The main objective is to demonstrate the effectiveness of compression garments in the EDS hypermobility type, especially in terms of symptomatic improvement joint pain.
The main outcomes expected of this study are:
- an improvement of the power and the peaks of couple of muscles rotators of shoulders.
- a decrease of the pains and the defects of articular stability of the shoulder
- an improvement of the quality of life and the functional independence of these patients
- Being tested
- short-sleeved vest CICATREX SED®)
- Keywords
- Ehlers-Danlos syndrome, hypermobility, Compression garment, pain, isokinetic evaluation
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Ehlers-Danlos Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-sleeved vest CICATREX SED®)Device
Each patient wears a compression custom-made garment (short-sleeved vest CICATREX SED®) according to the medical prescription during the first 4 weeks (BEFORE phase). Then each patient should not wear the compression garment for the next 4 weeks (AFTER phase).
| Study group | Role | What they receive |
|---|---|---|
| Patients with EDS hypermobility type | Experimental | Patients with EDS hypermobility type wearing compression garment then compression garment removal Receives: Device: short-sleeved vest CICATREX SED®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power (in watts) of the external rotators of the shoulder of the dominant arm measured by concentric isokinetic evaluation at a constant angular velocity of 180 °/s
The evaluations will be conducted 3 times:
- at the inclusion (D0)
- at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
- at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56) For each measurement, evaluations will be made with then without the compression garment.
Measured: 2 months follow-up
Secondary outcomes (4)
Level of pain expressed in the shoulders of patients
Evaluation of the level of pain each month by the physician investigator on Visual Analogue Scale :
- at the inclusion (D0)
- at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
- at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)
Measured: D0,D28,D56
Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
The score of quality of life is measured by self-administered questionnaire (SF-36 scale) at each follow-up visit:
- at the inclusion (D0)
- at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
- at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)
Measured: D0,D28,D56
Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
The score of satisfaction is measured by self-administered questionnaire (QUEST) at each follow-up visit:
- at the inclusion (D0)
- at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
- at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)
Measured: D0,D28,D56
Functional independence score measured by Health Assessment Questionnaire (HAQ)
The score of functional independence is measured by self-administered questionnaire (HAQ) at each follow-up visit:
- at the inclusion (D0)
- at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28)
- at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56)
Measured: D0,D28,D56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start23 May 2014
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos Syndrome Hypermobility TypeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle CHALEAT-VALAYER, MD, Principal investigator, Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144532
- Sponsor's protocol ID
- 2012-755
- Acronym
- VETCOSED
- Status last verified
- Dec 2025
- First submitted
- 7 May 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT02144532
- Acronym / sponsor ID
- VETCOSED / 2012-755
- Keywords
- Ehlers-Danlos syndrome, hypermobility, Compression garment, pain, isokinetic evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 May 2014 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 22 May 2014 (estimated)
- 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.
The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived and the most crippling.
Faced with insufficient effect of drug treatment, other alternatives have been proposed to relieve these patients. Compression garments have been developed. They appear as medical devices targeted specifically for patients with hypermobility EDS type: in the symptomatic treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle globulization, and in the functional improvement.
The VETCOSED study is a quasi-experimental study of type "Before / After", monocentric, open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which they do not carry this garment.
The main objective is to demonstrate the effectiveness of compression garments in the EDS hypermobility type, especially in terms of symptomatic improvement joint pain.
The main outcomes expected of this study are:
- an improvement of the power and the peaks of couple of muscles rotators of shoulders.
- a decrease of the pains and the defects of articular stability of the shoulder
- an improvement of the quality of life and the functional independence of these patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with EDS hypermobility type | Experimental | Device: short-sleeved vest CICATREX SED®)Patients with EDS hypermobility type wearing compression garment then compression garment removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ehlers-Danlos syndrome hypermobility type confirmed the diagnosis of a geneticist
- with an instability of one or both shoulders, painful or considered invalidating by the patient (recurrent dislocation or subluxation : at least once / month or at least 12 times / year)
- having a joint hypermobility syndrome (abnormal mobility and in a non-physiological axis), with a Beighton score of greater than or equal to 5 of 9
- age greater than or equal to 18 years
- size greater than or equal to 1 m 40
Key exclusion criteria (5 listed)
- hyperalgic episode in progress
- unstable cardiac disease
- previous history of shoulder surgery
- severe skin lesions,
- pregnancy in progress
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 |
|---|---|---|
| short-sleeved vest CICATREX SED®)Each patient wears a compression custom-made garment (short-sleeved vest CICATREX SED®) according to the medical prescription during the first 4 weeks (BEFORE phase). Then each patient should not wear the compression garment for the next 4 weeks (AFTER phase). | Device | Patients with EDS hypermobility type |
Primary outcome
Power (in watts) of the external rotators of the shoulder of the dominant arm measured by concentric isokinetic evaluation at a constant angular velocity of 180 °/s
Time frame: 2 months follow-up
The evaluations will be conducted 3 times: * at the inclusion (D0) * at the end of the BEFORE phase (4 weeks with the compression garment: D0 + 28) * at the end of the AFTER phase (4 weeks without the compression garment: D0 + 56) For each measurement, evaluations will be made with then without the compression garment.
4 secondary outcomes
Level of pain expressed in the shoulders of patients
Time frame: D0,D28,D56
Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
Time frame: D0,D28,D56
Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Time frame: D0,D28,D56
Functional independence score measured by Health Assessment Questionnaire (HAQ)
Time frame: D0,D28,D56
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 19 Dec 2025.
Related trials for Ehlers-Danlos Syndrome Hypermobility Type
Not yet recruitingObservational study
CLINICAL AND BIOLOGICAL DATABASE OF PATIENTS WITH NON-VASCULAR EHLERS-DANLOS SYNDROMES
Ehlers-Danlos Syndromes (EDS)
Not yet recruiting
Evaluation of the Role of Serum Tenascin-X Levels in the Diagnosis of Hypermobile Ehlers-Danlos Syndrome
Ehlers-Danlos Syndromes (EDS)
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Recruiting
STABLE Pilates for Hypermobility
Ehlers-Danlos Syndrome (EDS), Hypermobile EDS (hEDS)
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.
Emmanuelle CHALEAT-VALAYER, MD principal investigator
Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short-sleeved vest CICATREX SED®) in people with Ehlers-Danlos Syndrome Hypermobility Type, run by Hospices Civils de Lyon at 1 site 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 6 inclusion and 5 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Power (in watts) of the external rotators of the shoulder of the dominant arm measured by concentric isokinetic evaluation at a constant angular velocity of 180 °/s (time frame: 2 months follow-up). 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 19 Dec 2025.