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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Stasis Ulcer

Intervention / Treatment
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* Device: Erchonia ML Scanner (MLS)
* Device: Placebo Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one venous stasis ulcer, diagnosed according to a differential diagnosis methodology that satisfies both criteria supportive of the ulcer's venous origin and criteria that eliminates the ulcer as being indicative of non-venous origin. Diagnostic criteria to evaluate satisfaction of criteria that is supportive of venous origin of the ulcer will involve an evaluation of medical history and wound history variables; physical examination of the affected leg and ulcer site; and objective testing Resting Ankle Brachial Pressure Index (ABPI) of 0.8 or greater Venous Doppler ultrasound shows reflux in the suspect vein Clinical Etiologic Anatomic Pathophysiologic (CEAP) Classification System Class 6 Ulcer measures 5 to 20cm², inclusive, according to standardized computerized planimetry evaluation presenting venous leg ulcer has been present for 6 continuous weeks or longer Subject agrees to not partake in any other form of treatment for the ulcer throughout study participation, other than the standard of care treatment provided by the investigator as part of the study protocol Exclusion Criteria: Satisfaction of any exclusive diagnostic criteria that is considered indicative of an ulcer being of non-venous origin (e.g. arterial or mixed origin), or as having a non-venous component. This evaluation will include consideration of medical history and wound history variables; examination of the affected leg and ulcer site; and objective tests and measurements Resting Ankle Brachial Pressure Index (ABPI) of less than 0.8 Doppler ultrasound that shows absence of reflux in the suspect vein Fasting blood glucose (blood sugar) level of greater than 140 mg/dl that is indicative of current or potential diabetes Subject presents with factors that may significantly impede or delay the healing of chronic non-healing wounds, including known diabetes or other disordered glucose metabolic disease; malnutrition; collagen diseases such as Ehlers-Danlos syndrome; history of systematic glucocorticosteroid therapy; history of exogenous glucocorticosteroid therapy; and chemotherapeutic (antineoplastic) drug use Ulcer has significant bacterial infection, confirmed by a positive swab culture utilizing Levine's technique Ulcer has been present for less than 6 continuous weeks Ulcer is of CEAP Class 0 through 5, inclusive Ulcer measures less than 5cm² or greater than 20cm², according to standardized computerized planimetry evaluation Exposed bone tendon or fascia General skin disorder such as psoriasis or penicilitis Immunosuppressive disorder Hypercoagulable state Prior deep vein thrombosis Cellulites during the one-year period prior to study participation in Vasculitis or collagen vascular disease History of prior venous surgery Any concomitant illness(es) or medical condition(s) that would render the subject inappropriate for the study (i.e., renal failure, liver disease, connective tissue disorders, etc.) Active or recurrent cancer or currently receiving chemotherapy or radiation therapy Subject is taking a regimen of any medication(s) that may affect wound healing, including corticosteroid, chemotherapeutic and non-steroidal anti-inflammatory (NSAID) medications Developmental disability/significant psychological disorder that could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years Females currently pregnant or lactating or intending to attempt to become pregnant during the course of intended study participation Involvement in litigation/receiving disability benefits related to venous stasis ulcer(s). Other research participation in the 30 days prior to study qualification evaluation.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erchonia ML Scanner (MLS)<br>Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting 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: Erchonia ML Scanner (MLS)<br>* 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.<br>|
| Placebo Comparator: Placebo Laser<br>Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output. | Device: Placebo Laser<br>* Placebo Laser has no therapeutic output emitted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups | 'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure. | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ulcer Size | The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success. | Baseline and 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous stasis ulcer, leg ulcer