Laser Therapy for Venous Leg Ulcers

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

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 Overview

• Status: Recruiting
• Conditions: Varicose Ulcer; Venous Leg Ulcer; Stasis Ulcer
• Intervention / Treatment: Other: Standard Care; Device: High Intensity Laser Therapy

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed ElMeligie, Ph.D; Phone Number: 01159880001; Email: mmahm1989@gmail.com

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients aged 18 years up to 65 years.
2. Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux > 0.5 seconds).
3. Ulcer size between 1 cm² and 20 cm² at screening.
4. Ulcer duration of at least 4 weeks but not more than 12 months.
5. Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
6. Willing and able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
2. Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
3. Patients with a history of uncontrolled diabetes, defined as HbA1c level > 10%.
4. Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
5. Pregnant or breastfeeding women.
6. Patients with a history of malignancy or photosensitive skin disorders.
7. Prior history of skin grafting or flap surgery in the affected area within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care group; Participants will receive standard compression bandaging and wound care alone without high-intensity laser therapy. Bandaging will be applied weekly and wound care will be performed as per institutional protocols.	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).
Experimental: High Intensity laser therapy + Standard care group; Participants will receive high-intensity laser therapy 3 times per week for 8 weeks or until ulcer closure in addition to standard care.	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).; 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 Names: HILT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent 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.	Baseline, 4 weeks, 8 weeks and 12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From initial treatment until 4 weeks after final treatment, up to 12 weeks total.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): November 16, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: VLU-HILT-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No