NCT03716167 · Wake Forest University Health Sciences
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
What this study is 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.
View original scientific description
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.
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
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2025 · Source of record for eligibility and locations