NCT02395302

Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)

Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort in Patients With Venous Leg Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.

Detailed description

Subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. Subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.

Conditions

• Venous Leg Ulcer
• Chronic Venous Insufficiency
• Venous Stasis Ulcer
• Venous Ulcer
• Venous Insufficiency

Interventions

Type	Name	Description
DEVICE	Dual Action Pneumatic Compression	Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2015-03-23
• Last updated: 2017-03-27
• Results posted: 2017-02-23

Locations

6 sites across 1 country: United States