NCT01376050

Efficacy Study of the Application of Low Level Laser Light to Treat Venous Stasis Ulcers

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Venous Stasis Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether low level laser light therapy is effective as an adjunctive therapy to the healing of venous stasis leg ulcers.

Detailed description

A chronic venous stasis leg ulcer is a wound below the knee that fails to heal within 6 weeks. Venous stasis ulcers account for 80% to 90% of all leg and foot ulcers, affecting an estimated 500,000-600,000 people in the United States every year. Venous stasis ulcers account for the loss of 2 million working days and incur treatment costs around $3 billion dollars annually in the United States. Standard of care for venous stasis ulcers includes compression of the affected leg together with daily dressing changes to minimize swelling; debridement of the ulcer to remove dead tissue and bacteria; and daily wound Care dressing to keep the wound clean. Venous stasis ulcers typically have very lengthy and poor healing rates, with up to 50% remaining open and unhealed for 9 months or longer. Many patients suffer pain and sleep and mobility problems, impairing quality of life. Recurrence rates for venous stasis ulcers is very high, with about one third of treated individuals experiencing 4 or more episodes of ulceration. Low level laser light therapy (LLLT), with its proven tissue healing acceleration properties has recently gained attention as a simple, non-invasive alternative adjunctive therapy to assist in both wound closure and accelerated time to wound closure. Numerous histological trials have exhibited laser therapy's capacity to upregulate essential wound-healing factors such as vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), oxygen concentration, fibroblast proliferation, collagen synthesis, re-epithelialization, and tissue granulation. Clinically, the application of laser therapy has demonstrated promise, accelerating the rate of wound healing and tissue contracture.

Conditions

• Venous Stasis Ulcer

Interventions

Type	Name	Description
DEVICE	Erchonia ML Scanner (MLS)	Erchonia MLS comprises three 17.5 mW 635 nm diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
DEVICE	Placebo Laser	Placebo Laser has no therapeutic output emitted.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-06-20
• Last updated: 2015-12-11
• Results posted: 2015-12-11

Locations

2 sites across 2 countries: United States, France