Modelling Interface Pressure Applied by Superimposed Compression Bandages

December 28, 2016 updated by: Thuasne
The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42000
        • Service de Médecine Physique et de Réadaptation, CHU Bellevue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Compression bandages application and interface pressure measurements
Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher).

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)
Through study completion (one year)

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.
Through study completion (one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thuasne

Investigators

  • Principal Investigator: Pascal Giraux, MD, PhD, Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

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)?

UNDECIDED

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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