Clinical trial NCT03716167: Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
Official title: Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: laser
ulcer
wound
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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\<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.

Primary outcomes:
measure: Pain measured by survey
timeFrame: up to 17 weeks
Secondary outcomes:
measure: Venous Ulcer rate of healing
timeFrame: up to 17 weeks
measure: size of venous ulcer
timeFrame: up to 17 weeks
measure: Infectious complications
timeFrame: up to 17 weeks
measure: Wound aspect
timeFrame: up to 17 weeks
measure: Quality of Life Questionnaire
timeFrame: up to 17 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: WFUHS
name: Joseph Molnar, MD
role: PRINCIPAL_INVESTIGATOR
References: