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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Venous Leg Ulcer

Treatments: Device: Summus Laser; Device: Summus Laser Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03716167

IRB00040491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Laser Treatment

Experimental group

Description:

Summus Laser treatment with infrared light

Treatment:

Device: Summus Laser

Sham treatment

Sham Comparator group

Description:

Sham Summus Laser treatment with no infrared light

Treatment:

Device: Summus Laser Sham