Risk of Venous Thrombosis Clinical Trial
Official title:
Modelling Interface Pressure Applied by Superimposed Compression Bandages
| NCT number | NCT02803398 |
| Other study ID # | 2015-A01219-40 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | June 8, 2016 |
| Last updated | December 28, 2016 |
| Start date | February 2016 |
| Verified date | December 2016 |
| Source | Thuasne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Committee for the Protection of Personnes |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Médecine Physique et de Réadaptation, CHU Bellevue | Saint-Etienne |
| Lead Sponsor | Collaborator |
|---|---|
| Thuasne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Through study completion (one year) | No | |
| Secondary | Evaluation of the impact of soft tissue mechanical propreties on interface pressure | 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) | No |