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

The K-Laser Cube is an FDA cleared light-emitting device for applying infrared to provide
topical heating for the purpose of elevating tissue temperature for temporary relief of minor
muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and
promoting relaxation of the muscle tissue and to temporarily increase local blood
circulation.

There will be a total of 20 subjects involved in this study. The study will only involve
participants being treated at the Wake Forest University Health Sciences Wound Care Center.
Ten participants will be randomized to the treatment arm and receive therapeutic laser
therapy applied to the ulcer area. The other ten participants will receive a sham laser
therapy, where the light emitted by the laser is visible, but not powerful enough to provide
a therapeutic effect. During the first weekly visit, patients will have the wound debrided
(dead or dying tissue will be removed),and the size of the ulcer measured and photographed. A
wound dressing will be applied, followed by a compression wrap.

After one week patients will return to the Wound Care clinic and the size of the wound will
be evaluated. If the wound has decreased by less than 30%,the patient will be randomized into
the protocol. The patient will then have weekly visits, to include a survey, wound
measurements, survey, photos,and laser treatments. The length of the study is a maximum of 17
weeks (less if the patient heals faster). 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 between 4 - 8 out of ten 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
- Use of oral or IV administered antibiotics within one week prior to randomization

- Having tattoos in the region of skin above or adjacent to the ulcer where laser light
might be applied.