NCT06135246

Laser Therapy for Venous Leg Ulcers

Efficacy of High-Intensity Laser Therapy in the Management of Venous Leg Ulcers: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ahram Canadian University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.

Conditions

• Venous Leg Ulcer
• Varicose Ulcer
• Stasis Ulcer

Interventions

Type	Name	Description
DEVICE	High Intensity Laser Therapy	Participants will receive high-intensity laser therapy using an 810nm continuous wave diode laser (Multiwave locked System (MlS) provided by aSa). The laser applicator has a flat top hat beam profile with a spot size of 1cm2. The laser will be delivered in direct contact mode perpendicularly to the ulcer surface. Each 1cm2 area of the venous ulcer and a 1cm margin of periwound skin will be treated sequentially using a overlapping grid pattern to cover the entire ulcer area, with a 1 second exposure time per point. This results in a laser energy density of 4J/cm2 delivered to each point.
OTHER	Standard Care	Participants will receive standard compression bandaging and wound care as per institutional protocols, without any laser therapy. The compression bandaging protocol is based on recommendations from the American Venous Forum and American College of Phlebology guidelines (O'Donnell et al., 2014). Multi-layer compression bandages will be applied weekly by trained nurses, with layers including orthopedic padding, elastic bandages, and cohesive bandages. Bandages will be applied with high pressure at the ankle gradually decreasing up the leg, with an ankle pressure of approximately 40 mmHg (Mosti et al., 2015).

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Egypt