Venous Stasis Ulcer Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Venous Stasis Ulcers
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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