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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Summus Laser
* Device: Summus Laser Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Treatment<br>Summus Laser treatment with infrared light | Device: Summus Laser<br>* infrared laser treatment<br>|
| Sham Comparator: Sham treatment<br>Sham Summus Laser treatment with no infrared light | Device: Summus Laser Sham<br>* non-infrared light<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by survey | Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable | up to 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Ulcer rate of healing | healing rate to denote the length of time the patient has a wound | up to 17 weeks | 
| size of venous ulcer | wound measured length x width x depth | up to 17 weeks | 
| Infectious complications | Number of events of infectious complications | up to 17 weeks | 
| Wound aspect | % of granulation tissue | up to 17 weeks | 
| Quality of Life Questionnaire | Quality of life questions, 0 no trouble or 5 severe trouble | up to 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, ulcer, wound