- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02803398
Modelling Interface Pressure Applied by Superimposed Compression Bandages
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The measurement of the patients' legs shapes will be performed thanks to an optical scanner. The patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs.
Pressure measurements, applied by the different bandages, will be taken at the height of measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs.
2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann & Rauscher)) and their different combinations will be applied on the patient's legs.
The order of bandage application for each patient is randomized, but is the same for both legs. The order of the leg (right or left) on which the bandages are applied is randomized.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Saint-Etienne, France, 42000
- Service de Médecine Physique et de Réadaptation, CHU Bellevue
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female between 18 and 80 years old
- at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage)
- Hospitalized in the Service of Physical Medicine and Rehabilitation, in Saint-Etienne, France
- BMI between 20 and 35
- Able to stand for at least 10 minutes in a standing frame
- Signed informed consent to take part in the study
- Covered by a health insurance system
- Not taking part in another study which interfere with the results of the present study
Exclusion Criteria:
- Compression bandages contraindications
- Allergy to one of the different bandages components
- History of deep or superficial vein thrombosis
- Venous or arterial ulcer
- Cutaneous wound on the lower leg
- Cognitive, behavior or physical disorder preventing the communication and the active participation to a rehabilitation program, or a clinical study
- Patient under any legal protection (except curatorship)
- Not covered by a health insurance system
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient at risk of venous thrombosis
|
Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consistency between interface pressure [mmHg] given by the patient-specific simulation and the experimental pressure measurements for different positions (supine, sitting, standing) and the different bandage combinations.
Time Frame: Through study completion (one year)
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Through study completion (one year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the impact of soft tissue mechanical propreties on interface pressure
Time Frame: Through study completion (one year)
|
Patient's leg soft tissue mechanical properties are characterized for both patient's legs before bandage application.
The impact of this parameter on the measured interface pressure will be evaluated.
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Through study completion (one year)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pascal Giraux, MD, PhD, Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A01219-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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