Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
NCT ID: NCT03716167
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2018-07-27
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laser Treatment
Summus Laser treatment with infrared light
Summus Laser
infrared laser treatment
Sham treatment
Sham Summus Laser treatment with no infrared light
Summus Laser Sham
non-infrared light
Interventions
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Summus Laser
infrared laser treatment
Summus Laser Sham
non-infrared light
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Joseph Molnar, MD
Role: PRINCIPAL_INVESTIGATOR
WFUHS
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00040491
Identifier Type: -
Identifier Source: org_study_id
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