Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Summus Laser, Summus Laser Sham.
- Who it may be relevant to
- Registry conditions: Venous Leg Ulcer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
Overview
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.
Interventions
- Device Summus Laser
infrared laser treatment - Device Summus Laser Sham
non-infrared light
Primary outcome measures
- Pain measured by survey [Time frame: up to 17 weeks]
Secondary outcome measures (5)
- Venous Ulcer rate of healing [Time frame: up to 17 weeks]
- size of venous ulcer [Time frame: up to 17 weeks]
- Infectious complications [Time frame: up to 17 weeks]
- Wound aspect [Time frame: up to 17 weeks]
- Quality of Life Questionnaire [Time frame: up to 17 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT03716167 · IRB00040491