RecruitingNot Applicable

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

United States20 participantsStarted 2018-07-27

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain measured by survey

Timeframe: up to 17 weeks

Trial details

NCT IDNCT03716167

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Renea D Jennings, RN

336-716-6709 Renea.Jennings@Advocatehealth.org

View on ClinicalTrials.gov More Venous Leg Ulcer trials