VETCOSED
Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome
Sponsor study identifier
interventional
48
1 country
1
Study Start
May 23, 2014
Actual (reported)Primary Completion
April 5, 2018
Actual (reported)Study Completion
April 5, 2018
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 5, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2014
Actual (reported)May 22, 2014
Actual (reported)May 23, 2014
Actual (reported)April 5, 2018
Actual (reported)April 5, 2018
Actual (reported)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.
2 months follow-up
Level of pain expressed in the shoulders of patients
D0,D28,D56
Score of quality of life measured by the medical outcomes study Short-Form General Health Survey (SF-36 scale)
D0,D28,D56
Score of satisfaction measured by the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
D0,D28,D56
Functional independence score measured by Health Assessment Questionnaire (HAQ)
D0,D28,D56
Patients with EDS hypermobility type wearing compression garment then compression garment removal
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Lyon, 69322, France
Emmanuelle CHALEAT-VALAYER, MD
Médecine Physique et de Réadaptation, Centre Médico-Chirurgical de Réadaptation des Massues
48 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2014
First Posted
May 22, 2014
Study Start
May 23, 2014
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
April 5, 2018
Actual (reported)Study Completion
April 5, 2018
Actual (reported)Last Updated
December 19, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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