NCT02031627

Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

Physiologic Response to Varying Lymphoedema Compression Programs With the Flexitouch System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.

Detailed description

This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

Conditions

• Lower Extremity Lymphoedema
• Leg Lymphoedema

Interventions

Type	Name	Description
DEVICE	pneumatic compression - 1 hour per day	Pneumatic compression treatment once per day (1 hour)
DEVICE	pneumatic compression - 2 hours per day	pneumatic compression treatment twice per day in the AM \& PM (2 hours)
DEVICE	pneumatic compression - 4 hours per day	pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM \& PM (4 hours)

Timeline

• Start date: 2013-11-11
• Primary completion: 2019-03-31
• Completion: 2019-06-30
• First posted: 2014-01-09
• Last updated: 2021-07-20
• Results posted: 2021-07-20

Locations

1 site across 1 country: United Kingdom