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Near Infrared Laser Therapy
Laser Therapy for Venous Leg Ulcers
N/A
Recruiting
Led By Joseph Molnar, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ulcer duration longer than 4 weeks
Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 17 weeks
Awards & highlights
Study Summary
This trial will test whether laser therapy can provide pain relief and speed healing of venous leg ulcers.
Who is the study for?
This trial is for adults over 18 with chronic venous leg ulcers larger than 5 cm2 but smaller than 140 cm2, experiencing pain and having an ABI above 0.8. It's not for pregnant women, those who've had recent venous treatments or use immune-suppressing drugs, have certain comorbidities like uncontrolled diabetes, a BMI outside of the range of 15-50, or tattoos near the ulcer.Check my eligibility
What is being tested?
The study tests if Near Infrared Laser Therapy can relieve pain and speed up healing in venous leg ulcers. Participants will be randomly assigned to receive either real Summus Laser treatment or a sham (placebo) version to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include temporary discomfort at the site of application, skin irritation from heat exposure during laser therapy sessions, and possible changes in skin pigmentation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcer has lasted more than 4 weeks.
Select...
I have been diagnosed with venous insufficiency.
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I am 18 years old or older.
Select...
I have an ulcer on my lower limb in an area affected by poor blood flow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 17 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain measured by survey
Secondary outcome measures
Infectious complications
Quality of Life Questionnaire
Venous Ulcer rate of healing
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Laser TreatmentExperimental Treatment1 Intervention
Summus Laser treatment with infrared light
Group II: Sham treatmentPlacebo Group1 Intervention
Sham Summus Laser treatment with no infrared light
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,247 Total Patients Enrolled
Joseph Molnar, MDPrincipal InvestigatorWFUHS
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcer is between 5 and 140 cm2 in size after cleaning.I have not taken any antibiotics by mouth or IV in the last week.You have an autoimmune disorder.I am not taking immune-suppressing medications, including steroids.I have not had a vein treatment in the last 6 weeks.I am currently pregnant, nursing, or able to bear children.You have other health problems that could affect the way wounds heal, like nerve problems from pressure or uncontrolled diabetes with high Hb A1c levels.Your ankle brachial index (ABI) is higher than 0.8.My ulcer has lasted more than 4 weeks.I have been diagnosed with venous insufficiency.Your body mass index (BMI) is between 15 and 50.You have tattoos near the area where the laser treatment will be done.I haven't used any bioengineered products in the last 30 days and won't use them during the study.I am 18 years old or older.I have an ulcer on my lower limb in an area affected by poor blood flow.You have reported pain at a level of 2 or higher on a pain scale during your first visit for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Laser Treatment
- Group 2: Sham treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available in this clinical exploration?
"Affirmative. Clinicaltrials.gov hosts details which highlight that this medical trial, first launched on July 27th 2018, is actively enrolling patients. Currently 20 individuals are required to participate from 1 distinct site."
Answered by AI
How many people are currently partaking in this clinical exploration?
"Affirmative. According to data published on clinicaltrials.gov, this research endeavour went live on July 27th 2018 and has been modified as recently as July 26th 2022. It is presently looking for 20 individuals at one medical facility."
Answered by AI
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