Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy

The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.

Inclusion Criteria: * 18 yo or older * Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis * Ulcer location in area of stasis present on lower limb * Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement * Ankle brachial index (ABI) \> 0.8 * Ulcer duration longer than 4 weeks * Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study Exclusion Criteria: * Pregnant, nursing or child bearing potential * Venous ablation past 6 weeks and duration of study * Autoimmune disorder * Immune suppressive meds, Including steroids * Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c \> 9) * Use of bioengineered products 30 days before and during the duration of study * 15\