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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451188
Recruitment Status : Active, not recruiting
First Posted : March 1, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Cerecare

Tracking Information
First Submitted Date January 23, 2018
First Posted Date March 1, 2018
Last Update Posted Date October 7, 2019
Actual Study Start Date May 22, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03451188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 22, 2018)
  • 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.
Original Secondary Outcome Measures
 (submitted: February 23, 2018)
  • 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).
  • Proprioception disorders [ Time Frame: 6, 12, 18 and 24 months ]
    Assessment of proprioception disorders 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).
  • Tiredness [ Time Frame: 6, 12, 18 and 24 months ]
    Assessment of Tiredness by the FSS scale (Fatigue Severity Scale) [1-7].
  • 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).
  • Compliance [ Time Frame: 6, 12, 18 and 24 months ]
    By questioning the patient, estimate the number of hours of compression garments daily use.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Official Title Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes
Brief 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.

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population EDS patient
Condition Eds, Unspecified Type
Intervention Device: Cerecare compression garments
all Cerecare compression garments
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 23, 2018)
76
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03451188
Other Study ID Numbers SEDCARE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cerecare
Study Sponsor Cerecare
Collaborators Not Provided
Investigators Not Provided
PRS Account Cerecare
Verification Date October 2019