NCT02680834

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Dual Action Pneumatic Compression Device	Dual action pneumatic compression device used to treat chronic VLUs.
DEVICE	Multi-Layer Bandaging	Multi-layer bandaging used to treated chronic VLUs

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-02-12
• Last updated: 2020-02-19
• Results posted: 2020-01-30

Locations

18 sites across 1 country: United States