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

  • days left to enroll
  • participants needed
  • sponsor
    Wake Forest University Health Sciences
Updated on 4 October 2022
leg ulcer
venous insufficiency
Accepts healthy volunteers


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 Summus 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.

Condition Venous Leg Ulcer
Treatment K-Laser, K-Laser Sham, Summus Laser, Summus Laser Sham
Clinical Study IdentifierNCT03716167
SponsorWake Forest University Health Sciences
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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
<BMI <50
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
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