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

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.