NCT02015221

Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.

Detailed description

Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.

Conditions

• Chronic Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	Dual Action Pneumatic Compression Device	A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
DEVICE	Standard Compression Garments	Compression stockings with a 30-40mmHg level of compression.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2013-12-19
• Last updated: 2016-12-15
• Results posted: 2016-12-15

Locations

11 sites across 1 country: United States