NCT01549860

Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Celleration, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.

Detailed description

The study compared the treatment effect of non-contact low frequency ultrasound in addition to standard of care versus standard of care alone in healing chronic venous leg ulcers in subjects who had documented venous stasis and reflux. Subjects that were screened and met the major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist wound healing dressings, and debridement for a two week run-in period. If their study ulcer did not decreased by greater than 30% they were eligible for randomization. The primary endpoint was wound area reduction after four (4) weeks of study treatment. The study was performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis and a wound recidivism registry that are ongoing.

Conditions

• Venous Insufficiency
• Venous Reflux
• Lower Extremity Ulcer

Interventions

Type	Name	Description
DEVICE	MIST Therapy	Non-contact low frequency ultrasound therapy

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-05-01
• Completion: 2015-04-01
• First posted: 2012-03-09
• Last updated: 2015-07-30
• Results posted: 2015-07-30

Locations

1 site across 1 country: United States