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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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.
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).
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, Egypt
RECRUITINGPercent change in ulcer area from baseline to end of treatment
Ulcer area will be measured by tracing the wound perimeter on acetate paper and entering into image analysis software to calculate area in cm2. Percent change in ulcer area will be calculated as (area at end of treatment - area at baseline) / area at baseline x 100.
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks after randomization
Rate of complete ulcer closure at end of treatment
Complete closure is defined as full re-epithelialization of the ulcer with no drainage. Assessed by clinical examination and tracing wound area as 0cm2. Reported as proportion of participants with complete closure.
Time frame: Single time point at end of study at 12 weeks
Time to complete ulcer closure
Number of days from initial treatment until first point at which complete ulcer closure is achieved and maintained through end of treatment period.
Time frame: From baseline (week 0) until complete closure, up to 12 weeks.
Changes in Quality of life
The Cardiff Wound Impact Schedule is a condition-specific quality of life questionnaire designed for patients with chronic wounds. It contains 15 questions assessing physical symptoms and daily living. Each item is rated on a 4-point Likert scale from 1 (never) to 4 (all the time). Total score ranges from 15 to 60, with higher scores indicating poorer quality of life.
Time frame: Change in total score on the Cardiff Wound Impact Schedule will be assessed from baseline (week 0), 4 weeks, 8 weeks and 12 weeks after randomization
Incidence of treatment-related adverse events
Adverse events will be graded per CTCAE v4.0. Number of participants experiencing each severity grade of adverse event related to study treatment will be reported.
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Time frame: From initial treatment until 4 weeks after final treatment, up to 12 weeks total.