Using laser therapy to treat pain and promote healing in chronic venous leg ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of near-infrared laser therapy in providing pain relief and enhancing wound healing in patients with chronic venous leg ulcers. A total of 20 participants will be enrolled, with half receiving actual laser treatment and the other half receiving a sham treatment. Participants will undergo weekly assessments, including wound measurements and surveys, over a maximum duration of 17 weeks. The study aims to determine if laser therapy can significantly improve healing outcomes compared to a placebo.

Why it matters

Who can join: the full rules

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 it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Joseph Molnar, MD — Wfuhs
• Study coordinator: Renea D Jennings, RN
• Email: Renea.Jennings@Advocatehealth.org
• Phone: 336-716-6709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.