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Near Infrared Laser Therapy for Venous Leg Ulcers

This study is testing if a device called Summus Laser can help relieve pain and speed up the healing of chronic venous leg ulcers (open sores on the leg due to poor blood flow). The laser works by emitting infrared light that warms the skin, temporarily increasing blood flow and relieving minor muscle and joint pain. You may be able to join if you are 18 or older, have a venous leg ulcer between 5 and 140 square centimeters, and meet other health criteria. The main goal is to see if the laser reduces pain, which will be measured using surveys for up to 17 weeks. The study is currently recruiting 20 participants.

Study design
This is a randomized controlled study with 20 participants. Half will receive the Summus Laser treatment, and the other half will receive a sham (inactive) laser treatment.
What's involved
You will have an initial visit for wound debridement and measurement. If your wound hasn't decreased by 30% after one week, you'll be randomized and have weekly visits for surveys, wound measurements, photos, and laser treatments.
Compensation
Not stated in the trial record.
Follow-up
Pain will be measured using surveys for up to 17 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03716167

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

Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~20 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Summus LaserSummus Laser Sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain measured by survey
Measured over up to 17 weeks

Conditions

Venous Leg Ulcer

Explore related trials

Stasis ulcer

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Joseph Molnar, MD · PRINCIPAL_INVESTIGATOR · WFUHS

Who to contact

Renea D Jennings, RN
[email protected]
336-716-6709
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pain measured by surveyup to 17 weeks

    Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable