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VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging

Venous Leg Ulcer Clinical Trial

Official title:
Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study

Clinical Trial Summary

The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.

Clinical Trial Description

Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks. Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02680834
Study type Interventional
Source Tactile Medical
Contact
Status Terminated
Phase N/A
Start date February 2016
Completion date June 2017
View Details
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