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



Status:Recruiting
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:10/26/2018
Start Date:July 27, 2018
End Date:October 2019
Contact:Renea D Jennings, RN
Email:rjenning@wakehealth.edu
Phone:336-716-6709

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Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers

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.

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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Joseph Molnar, MD
Phone: 336-716-6709
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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