Laser Therapy for Venous Leg Ulcers

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
Venous Leg UlcerVaricose UlcerStasis Ulcer
Interventions
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).

Trial Locations (1)

3221405

RECRUITING

Outpatient clinic of faculty of physical therapy, Ahram Canadian University, Al Ḩayy Ath Thāmin

All Listed Sponsors
lead

Ahram Canadian University

OTHER